(infection plus two or more SIRS). Validation of the ... is suspected infection plus SIRS. .... (s epsis-related) organ failure ass essmen t. (SO. F. A) ! 2 scores. System. Score ... Urin e ou tput,. mL/d.
bar punctures or transfontanelle ventricular taps). The au- thors of published .... ters routinely perform serial lumbar punctures or serial direct ventricular taps to ...
thick (>4 mm) melanoma: multi-center, retrospective study of 291 Japanese ... Materials and methods: A review of the melanoma database collected from.
Low-vision specialists at 7 low-vision care and vision rehabili- tation centers ..... Hodapp E, Parrish RK, Anderson DR. Clinical Decisions in Glaucoma. St Louis,.
technique for the management of hallux valgus that provides ..... Lapidus P. The operative correction of the metatarsus varus primus in hallux · valgus.
Nov 4, 2014 - Isodose, median % (IQR). 80 (76â85%). 77 (72â80%). 81 (80â81%). 0.24. Dose, median Gy (IQR). 1800 (1750â1950). 2050 (2000â2175).
Dec 24, 2014 - Composite restorations placed in primary canines have low survival rates. ... implemented with a preventive program, behavioural remod- elling, and a follow-up ... procedures, including tooth type and restoration type, were.
May 2, 2014 - nurse and/or surgeon marked the stoma area; this occurred 1 day before or on the day of surgery according to Wound. Ostomy ... wound care nurses in some centers and stoma and wound ..... WHO guidelines for safe surgery:.
Apr 6, 2011 - (SAEs), including deaths and second cancers, adverse events not qualifying as .... groups (3.9% vs 20.9%, P < .001), despite a comparable median age (45 ..... 23. de Lavallade H, Apperley JF, Khorashad JS, et al. Imatinib for ...
tive study5 involving 174 single-tooth ITI implant restorations suggested ... Loosening of a solid conical abutment occurred in 1 additional patient, for cumulative .... recommended torque at the time of placement. No further loosening was ...
Purpose: Epidemiological and clinical study of retinal detachment associated with atopic dermatitis. Methods: A multicenter retrospective study. Results: We ...
In this study, we investigated the outcomes of tuberculosis treatment at Felege Hiwot Referral Hospital in northwest Ethiopia. According to the World Health ...
To determine the approximate incidence and clinical features of pernicious anemia in a. Korean population, we retrospectively analyzed clinical data for patients with pernicious anemia who were diagnosed between 1995 and 2010 at five hospitals in Chu
observed at the scene of poisoning for 56 patients (10.8%), including violence to ..... sants (TCA) in four, BZO in 31, barbiturates (BAR) in 14, .... Treatment is sup-.
Capsulotomy was then performed to expose the ankle mortise so that .... Chamley J. Compression arthrodesis of the ankle and shoulder. J Bone. Joint Surg ...
The International Journal of Oral & Maxillofacial Implants 737. Levine et .... following immediate placement. 31(47) ... RPD = removable partial denture. 175. 125.
In selected patients on background oral PAH therapy, transitioning from parenteral prostacyclin to inhaled .... years post-surgical repair); human immunodeficiency ..... Kallen AJ, Lederman E, Balaji A, Trevino I, Petersen EE, Shoulson R, et al.
paid consultant to Orthopedics Overseas and Zimmer Biomet. ... minimally invasive surgical technique may be attributed to expanding knowledge of surgical ...
of Periodontology & Oral Implantology, University Hospital, Univer- .... complications. 2 ... The implant is installed after pretapping of the bone to avoid too much friction, ..... Misch CE. Implant design considerations for the posterior regions of
desmoplastic melanoma and neurotropic melanoma, melanoma arising from blue nevus, melanoma arising in giant congenital nevus, childhood melanoma, ...
Anemia, renal dysfunction, elevated calcium and skeletal lytic lesions ... Received: 22 February 2017 | Revised: 30 March 2017 | Accepted: 3 April 2017.
Objective: The anatomy and function of the superior laryngeal nerve (SLN) ... The prevalence of SLN injury as a consequence of cervical spine surgery is difficult.
Thirty-day all-cause mortality was based on patient status. 30 days after the end ...... Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER,. Fosheim GE .... Gurnani K, Khouri H, Couture M, Bergeron MG, Beauchamp D,. Carrier D.
The Journal of Foot & Ankle Surgery xxx (2011) 1–7
Contents lists available at ScienceDirect
The Journal of Foot & Ankle Surgery journal homepage: www.jfas.org
A Multicenter Retrospective Review of Outcomes for Arthrodesis, Hemi-Metallic Joint Implant, and Resectional Arthroplasty in the Surgical Treatment of End-Stage Hallux Rigidus Paul J. Kim, DPM, FACFAS 1, Daniel Hatch, DPM, FACFAS 2, Lawrence A. DiDomenico, DPM, FACFAS 3, Michael S. Lee, DPM, FACFAS 4, Bruce Kaczander, DPM, FACFAS 5, Gary Count, DPM, FACFAS 6, Marc Kravette, DPM, FACFAS 7 1
Associate Professor, Department of Plastic Surgery, Georgetown University Hospital, Washington, DC Private Practice, Foot and Ankle Center, Greeley, CO 3 Private Practice, Ankle and Foot Care Centers, Youngstown, OH 4 Private Practice, Capital Orthopedics and Sports Medicine, Clive, IA 5 Private Practice, Michigan Foot and Ankle Center, Southﬁeld, MI 6 Private Practice, Scituate Podiatry Group, Inc., Scituate, MA 7 Surgeon, Department of Orthopedics, Virginia Mason Medical Center, Seattle, WA 2
a r t i c l e i n f o
a b s t r a c t
Level of Clinical Evidence: 3 Keywords: arthritis bone foot joint replacement metatarsal phalanx surgery toe
This is a retrospective, multicenter study examining the long-term results for the treatment of end-stage hallux rigidus using 3 different surgical procedures. A total of 158 subjects (105 females and 53 males) were included in the present study. They had undergone 1 of the following surgical procedures: arthrodesis, hemi-implant, or resectional arthroplasty. The long-term results for the subjective assessment of pain, function, and alignment, as well as objective radiographic and physical ﬁndings, were examined. The median interval to postoperative follow-up for the 3 procedure groups was 159 weeks. No statistically signiﬁcant difference was found in age or the number of subjects included in the 3 treatment groups (p ¼ .11 and p ¼ .16, respectively). The body mass index was signiﬁcantly different statistically among the 3 treatment groups, with the hemi-implant group representing a smaller body mass index compared with the other procedures (p ¼ .007). No statistically signiﬁcant difference was found in the subjective outcomes among the 3 treatment groups using the American College of Foot and Ankle Surgeons’ First Metatarsophalangeal Joint and First Ray Scoring Scale (patient questionnaire) or the modiﬁed Hallux Metatarsophalangeal-Interphalangeal Scale of the American Orthopedic Foot and Ankle Society (p ¼ .64 and p ¼ .14, respectively). Furthermore, the correlation coefﬁcient between the 2 subjective scoring scales was 0.78, statistically signiﬁcant and reﬂecting a moderate to high correlation (p < .001). The results of the radiographic and clinical evaluation revealed that metatarsalgia was the most common ﬁnding for the arthrodesis group (9.8%), bony overgrowth into the joint for the hemi-implant group (28.3%), and ﬂoating hallux for the resectional arthroplasty group (30.9%). The results of our study suggest that all 3 surgical procedures are viable options for the treatment of end-stage hallux rigidus. Ó 2011 by the American College of Foot and Ankle Surgeons. All rights reserved.
Hallux rigidus is a degenerative process that affects the integrity of the ﬁrst metatarsophalangeal joint (MTPJ). Patients afﬂicted with this condition report pain during ambulation and in shoe gear (1). Clinically, a decrease or absence of range of motion, along with pain and/or
Financial Disclosure: None reported. Conﬂict of Interest: None reported. Address correspondence to: Paul J. Kim, DPM, FACFAS, Associate Professor, Department of Plastic Surgery, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC 20007-0469. E-mail address: [email protected] (P.J. Kim).
crepitus, is noted (2). Radiographically, typical joint destructive changes are identiﬁed, including narrowing and ﬂattening of the joint space, subchondral sclerosis, cystic changes, joint debris, and dorsal spurring (2,3). Intraoperatively, a direct examination of the joint surfaces reveals denudation of cartilage, cystic changes to the surrounding bone, and periarticular osteophytic spurring. The lack of a cartilage interface is thought to be the cause of the pain experienced by those with this degenerative process. Hallux rigidus is progressive and can be initiated by an acute traumatic event. However, the most common cause involves a biomechanical etiology (4). This can include increased pronatory
1067-2516/$ - see front matter Ó 2011 by the American College of Foot and Ankle Surgeons. All rights reserved. doi:10.1053/j.jfas.2011.08.009
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
forces, resulting in a decrease in the available range of motion at the ﬁrst MTPJ, causing dorsal jamming experienced within the joint (5,6). Underlying anatomic variations, such as a long ﬁrst metatarsal and tightness of the plantar fascia, can also potentiate this process. The repetitive traumatic process continues to destroy the cartilage within the joint, causing exposure of the underlying subchondral bone. The inability of the chondral surfaces of the joint to regenerate contributes to making this an irreversible process. A variety of surgical treatment options are available for hallux rigidus once nonoperative methods have failed. The primary goal of surgical treatment of hallux rigidus is pain relief. The secondary goal is improvement in overall function. These surgical treatment options are largely dependent on the stage or grade of hallux rigidus; however, consensus is lacking regarding the most accurate classiﬁcation system (7). The classiﬁcation system proposed by Coughlin and Shurnas (8) systematically examines the range of motion, radiographic ﬁndings, and clinical ﬁndings to grade the hallux rigidus. This classiﬁcation scale progresses from grade 0 to grade 4. With each advancing grade, the degree of degeneration of the ﬁrst MTPJ increases. This classiﬁcation system is widely accepted and hence was used in the present study to standardize our evaluation. It is generally accepted that 2 broad categories of procedures exist for the surgical treatment of hallux rigidus. The ﬁrst broad category is considered “joint sparing” procedures, which include cheilectomy, sesamoid excision, arthrodiastasis, and decompression osteotomy (9,10). As the name implies, these procedures attempt to maintain the integrity of the ﬁrst MTPJ. This category of procedures is generally used for earlier stages of this degenerative process. The second category is considered “joint destructive” procedures, including joint fusion, joint replacement, and joint resection (Figs. 1 to 3) (9–11). This category of procedures eliminates the anatomic joint and is usually reserved for the end-stage of this disease process. This latter category was the focus of the present study. Arthrodesis of the ﬁrst MTPJ was initially reported by Broca (12) in 1852 and popularized by McKeever (13). This procedure of fusing the ﬁrst MTPJ has been successfully used for decades (14–16). If fusion is achieved, the results of the procedure are long lasting. Although arthrodesis is typically used as a primary procedure for hallux rigidus, it has also been advocated as a salvage procedure for failed resectional arthroplasties (17–19). Joint implant arthroplasty is a surgical technique involving the use of engineered materials placed into the ﬁrst MTPJ, thereby creating an artiﬁcial joint. Swanson et al (20) popularized a single and double stemmed, hinged type silicone implant in the 1970s. These implants have evolved in materials and design over the decades. The materials used have included silicone, ceramics, polymers, and metal alloys. Hemi-implants (hemi-arthroplasty) are 1-piece constructs that are placed at the base of the proximal phalanx or the head of the ﬁrst metatarsal. These types of implants have grown in popularity owing to their simple application and have yielded good results (21–23). Resectional arthroplasty (Keller procedure), since its introduction to published studies in the early 1900s, has been used successfully for decades (24–26). Although this procedure has been modiﬁed over the years, it has been a viable surgical option for the treatment of hallux rigidus (27–29). This technique involves the resection of the base of the proximal phalanx of the hallux, thereby removing the degenerated joint interface. Robust long-term studies examining the efﬁcacy for the surgical treatment of end-stage hallux rigidus are lacking. There are conﬂicting and unclear published reports regarding arthrodesis, hemi-implant arthroplasty, and resectional arthroplasty. To our knowledge, no large, long-term published outcome studies have directly compared these 3 surgical techniques. The present study was a multicenter, retrospective, comparative study examining the
Fig. 1. Arthrodesis. Postoperative dorsal-plantar radiographic view demonstrating result of arthrodesis of ﬁrst metatarsophalangeal joint using a plate and a single partially threaded cortical lag screw.
long-term outcomes of arthrodesis, hemi-metallic joint implants, and resectional arthroplasty in patients with end-stage hallux rigidus. Patients and Methods Investigative Sites A general call for investigative site participation was conducted through print media and the website by the American College of Foot and Ankle Surgeons (ACFAS). The potential sites were required to meet the following criteria, outlined in the application: (1) 1-year contractual commitment to the study; (2) the investigator for each site must be a fellow or an associate of the ACFAS; (3) the investigator must have performed a minimum of 50 surgical procedures for the treatment of hallux rigidus; (4) the investigator must have performed all 3 procedures; and (5) the investigator must have a professional reputation for scholarly activity. Fourteen applications were reviewed by the study director (P.J.K.). Five sites were initially selected to participate according to these criteria and their geographic location. An attempt was made to prevent regional clustering of investigative sites by selecting sites from different geographic regions across the United States. A formal statistical clustering prevention plan was not conducted. Within the ﬁrst year of the study, 2 sites were withdrawn by the study director. One of these sites was
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
Fig. 2. Hemi-implant arthroplasty. Postoperative dorsal-plantar radiographic view demonstrating result of hemi-implant arthroplasty of ﬁrst metatarsophalangeal joint.
Fig. 3. Resectional arthroplasty. Postoperative dorsal-plantar radiographic view demonstrating result of resectional arthroplasty of ﬁrst metatarsophalangeal joint.
withdrawn because of the lack of study progress and subject enrollment. The other site was withdrawn because multiple pages of data were either not collected or missing. The data collected from these sites were not used in the ﬁnal analysis. Two replacement sites were added according to the same criteria as listed. After an interim power analysis was conducted, an additional investigational site was added to increase the power of the study. Hence, the data from 6 sites were used for the ﬁnal statistical analysis. Each investigative site was provided a detailed study binder that outlined the speciﬁc instructions for proper study execution and data collection. The investigative sites were provided a stipend to participate in the present study. All investigative sites received approval by the Western Institutional Review Board (Olympia, WA), which served as the centralized institutional review board for all participating investigational sites.
Patients The patients who underwent arthrodesis, hemi-implant arthroplasty, or resectional arthroplasty for the treatment of end-stage hallux rigidus, with a minimum follow-up period of 12 months, were recruited into the present study. The patients were identiﬁed through a review of charts for patients with grade 3 or 4 hallux rigidus using the Coughlin and Shurnas Classiﬁcation System for Hallux Rigidus (8). The patients were contacted by telephone and asked to return to their surgeon’s (site investigator) ofﬁce to collect both subjective and objective information. The patients were excluded from the study if they had a history of seronegative or seropositive arthropathy. The patients were compensated for their participation. Measurement Tools
Surgical Technique No standardized surgical technique was used for any of the 3 procedures. A range of ﬁxation devices was used for the arthrodesis procedure, including the use of wires, screws, and/or plates. The type of hemi-implant used differed from surgeon to surgeon; however, all involved the use of a hemi-implant placed at the base of the proximal phalanx. The technique for the implantation of the hemi-implant also differed from surgeon to surgeon. The performance of the resectional arthroplasty was relatively consistent. However, the amount of the proximal phalanx removed and the type of tissue used for interposition differed from surgeon to surgeon.
Demographic information was collected, including age, gender, weight, height, postoperative time to follow-up, and type of procedure performed. Outcome measures were obtained from both the patient and the site investigator. The site investigator performed a radiographic and clinical evaluation speciﬁc to each procedure performed. The clinical evaluation included a physical examination of the surgical limb, and these ﬁndings were recorded by the site investigator. The physical examination included pain with palpation about the joint and forefoot and the relative position of the hallux. Radiographic examination included 3 weight bearing views (dorsal-plantar, lateral, and oblique), which were reviewed by the site investigator. The radiographic examination included noting any osseous changes around the joint, the relative position of the ﬁrst
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
ray, and the position of the joint implant. Included in the site investigator evaluation was whether a suboptimal result required revisional surgery and what type of revisional surgery was conducted. The subjects completed 2 patient-reported outcomes questionnaires assessing pain, function, and alignment/appearance. One of these questionnaires used the First Metatarsophalangeal Joint and First Ray Scoring Scale (patient questionnaire) of the ACFAS, which uses a 50-point scale divided into pain (30 points), functional capacity (15 points), and appearance (5 points) (Table 1) (30). The other outcomes questionnaire used was the modiﬁed Hallux Metatarsophalangeal-Interphalangeal Scale of the American Orthopedic Foot and Ankle Society (AOFAS), which uses a 100-point scale divided into pain (40 points), function (40 points), and alignment/cosmesis (20 points) (Table 2) (32,33).
Table 2 Modiﬁed Hallux Metatarsophalangeal-Interphalangeal Scale of the American Orthopedic Foot and Ankle Society Parameter
None Mild Occasional Severe, almost always present
40 30 20 0
No limitations No limitations of daily activities, such as employment responsibilities or recreational activities Limited daily and recreational activities Severe limitation of daily and recreational activities
No restrictions Restricted to sneakers, wide shoes Restricted to modiﬁed shoes
A total of 158 patients (105 females and 53 males) were enrolled in the present study and underwent 51 arthrodesis, 52 hemi-implant, and 55 resectional arthroplasty procedures (Table 3). The mean age was 60.5 9.7 (range 36 to 84) years for the arthrodesis group, 61.4 7.5 (range 45 to 85) years for the hemi-implant group, and 64.3 11.3 (range 39 to 92) years for the arthroplasty group. No signiﬁcant difference was found in the mean age (p ¼ .11) or number of patients in each group (p ¼ .16) for the 3 procedures. The height and weight measurements were converted into the body mass index (BMI). A signiﬁcant difference was found in the BMI among the 3 groups (p ¼ .007). Those who underwent a hemi-implant procedure had Table 1 First Metatarsophalangeal Joint and First Ray Scoring Scale (patient questionnaire) of the American College of Foot and Ankle Surgeons Parameter
Function Activity limitations
Statistical Analysis Differences in the demographic information among the 3 procedure groups was statistically analyzed using 1-way analysis of variance, chi-square, and Kruskal-Wallis tests. A comparison between the right and left legs was conducted using a related samples Wilcoxon test for patients with bilateral data points. The patient-reported outcome measures among the 3 procedure groups were statistically compared using a Kruskal-Wallis test. The results of the ACFAS and modiﬁed AOFAS subjective questionnaires were not normally distributed; therefore, the median scores were statistically compared using the Spearman’s rank correlation coefﬁcient. Statistical signiﬁcance was deﬁned at p .05. The surgeon’s clinical and radiographic evaluations were tabulated, but no statistical comparison was performed owing to the lack of consistency of ﬁndings among the 3 procedures. A power calculation was also conducted at a signiﬁcance level of 0.05, power of 0.80, medium effect size of 0.25, and large effect size of 0.40. Using these limits, the sample size needed in each group to detect a medium effect was 53, with 22 patients needed to detect a large effect. All statistical calculations were performed using Statistical Package for Social Sciences, version 14.0, for Windows (Armonk, NY).
Pain: Over the past month, how much has your foot pain limited your daily activities? I have no pain with normal activities I have slight pain or occasional pain but no limitation of activities I have moderate pain limiting some activities I have pain and signiﬁcant limitation of activities I have severe pain that limits almost all activity Appearance: How would you rate the appearance of your big toe joint? (31) I like it very much I mostly like it I’m not sure either waydneutral I mostly do not like it I deﬁnitely dislike it Functional capacities: How frequently do you have pain wearing shoes? I am able to continuously wear any type of shoe I am able to wear any type of shoe most of the time I am able to wear only walking, athletic, or casual shoes I am able to wear only special order, orthopedic or custom-made shoes
30 22 14 6 0 5 4 3 2 0 15 10 5 0
Adapted from Zlotoff HJ, Christensen JC, Mendicino RW, Schuberth JM, Schwartz NH, Thomas JL, et al. ACFAS Universal Foot and Ankle Scoring System: First Metatarsophalangeal Joint and First Ray (module 1). J Foot Ankle Surg 41:2–5, 2002.
Good, pleased Fair Poor, unhappy
20 10 0
Modiﬁed scale adapted from Roukis et al (33), with permission; original scale from Kitaoka et al (32).
a statistically signiﬁcantly lower BMI than those who underwent arthrodesis (p ¼ .050) or arthroplasty (p ¼ .007). The median postoperative interval was 194 weeks for the arthrodesis group, 188 weeks for the hemi-implant group, and 124 weeks for the resectional arthroplasty group. Overall, the median postoperative follow-up period was 159 weeks. The median postoperative follow-up period was not signiﬁcantly different among the 3 procedure groups (p ¼ .052). Statistical calculations were performed to detect differences in the patient-reported outcome scores. No statistically signiﬁcant difference was observed between the right and left limbs for the cumulative outcome scores for either the ACFAS or the modiﬁed AOFAS scores (p ¼ .514 and p ¼ .689 respectively). The median total ACFAS score was 42 for the arthrodesis procedure group, 42 for the hemi-implant procedure group, and 44 for the resectional arthroplasty procedure group (Table 4). No statistically signiﬁcant difference was found among the 3 procedure groups (p ¼ .642). The median total modiﬁed AOFAS score was 90 for the arthrodesis procedure group, 80 for the hemi-implant group, and 92 for the resectional arthroplasty procedure group. No statistically signiﬁcant difference was found among the 3 procedure groups (p ¼ .138). The ACFAS scores were multiplied by 2 to compare these scores to the modiﬁed AOFAS scores. The correlation coefﬁcient between the ACFAS and AOFAS scores was 0.783, which was statistically signiﬁcant, revealing a moderate to high correlation between the results of the 2 scoring scales (p < .001). The surgeon’s clinical and radiographic ﬁndings were tabulated (Table 5). The following ﬁndings were identiﬁed in the arthrodesis group: metatarsalgia (9.8%), nonunion (7.8%), malalignment (7.8%), hallux interphalangeal joint pain (3.9%), and delayed union (2%)
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
Table 3 Statistical description for the 3 procedure groups
Table 5 Results of surgeons’ clinical and radiographic examination
Arthrodesis Hemi-Implant Resectional Arthoplasty p Value (n ¼ 51) (n ¼ 52) (n ¼ 55)
Age (y) 60.5 9.7 61.4 7.5 Gender (n) Female 31 32 Male 20 20 BMI (kg/m2) 28.1 5.6 25.6 3.8 BMI (95% CI) 26.5–29.6 24.6–26.7 Median postoperative 194 188 period (wk)
64.3 11.3 42 13 28.7 5.8 27.1–30.3 124
Age and BMI calculated as mean standard deviation. Tukey’s highly signiﬁcant difference post hoc test conducted on BMI data to detect where the difference lies between groups. Statistical comparison among 3 groups for postoperative period calculated using nonparametric test (Kruskal-Wallis). Arthrodesis vs. hemi-implant, p ¼ .050; hemi-implant vs. resectional arthroplasty, p ¼ .007; and resectional arthroplasty vs. arthrodesis, p ¼ .801. Abbreviations: BMI, body mass index; CI, conﬁdence interval.
(Table 5). Three revision surgeries were performed, with 2 fusions using a bone graft and 1 fusion not requiring a bone graft. The following ﬁndings were identiﬁed in the hemi-implant group: bony overgrowth into the joint (28.8%), radiolucency around the implant (19.2%), migration of the implant (15.4%), dorsal drift of the hallux (11.5%), cystic changes around the implant (7.7%), metatarsalgia (7.7%), elevation of the ﬁrst ray (5.8%), subsidence of the implant (1.9%), and sub-ﬁrst metatarsal pain (1.9%). Two revision surgeries were performed and involved the removal of the implant with resectional arthroplasty performed in both cases. The following ﬁndings were identiﬁed in the arthroplasty group: ﬂoating hallux (30.9%), metatarsalgia (14.5%), sesamoiditis (5.5%), and remodeling/regrowth at the head of the ﬁrst metatarsal (3.6%). No revision surgeries were performed. Discussion To our knowledge, this is the ﬁrst multicenter study comparing the long-term outcomes for the 3 most commonly performed surgical procedures for the treatment of end-stage hallux rigidus. Our results indicate that all 3 procedures result in high overall patient subjective scores at follow-up of an average of approximately 3 years. Furthermore, there did not appear to be a procedure selection bias based on the patient’s age. The BMI of the hemi-implant patients was signiﬁcantly lower statistically than that of the other 2 procedure groups. However, we cannot conclude that the surgeon selected patients with a lower BMI to have a hemi-implant procedure performed. Owing to the long-term nature of the present study, there was signiﬁcant time to observe any complications. The complications we observed in our study are consistent with those reported in the published data for each procedure. The most prevalent complication for arthrodesis was a combined 9.8% rate for nonunions and delayed unions. This correlates with the reported rates of nonunion for primary arthrodesis of 2% to 13% (34–37). The hemi-implant arthroplasty group revealed an osseous overgrowth rate of 28.8% and
Table 4 Median subject-reported ACFAS and modiﬁed AOFAS scores for 3 procedures Questionnaire
Arthrodesis (n ¼ 51)
Hemi-Implant (n ¼ 52)
Resectional Arthoplasty (n ¼ 55)
ACFAS Modiﬁed AOFAS
Abbreviations: ACFAS, American College of Foot and Ankle Surgeons; AOFAS, American Orthopedic Foot and Ankle Society.
Arthrodesis (n ¼ 51) Metatarsalgia Nonunion Malalignment Interphalangeal joint pain Delayed union Revisional surgery and type Fusion with bone graft Fusion without bone graft Hemi-implant (n ¼ 52) Bony overgrowth into joint Radiolucency around implant Migration of implant Dorsal drift of hallux Metatarsalgia Cystic changes around implant Elevation of ﬁrst ray Subsidence of implant Sub-ﬁrst metatarsal pain Revisional surgery and type Keller arthroplasty Resectional arthoplasty (n ¼ 55) Floating hallux Metatarsalgia Sesamoiditis Regrowth/remodeling Revisional surgery and type
Clinical and radiographic ﬁndings for each procedure type listed in order from most common to least common.
lucency about the implant rate of 19.2%. These observations did not necessitate the need for removal and did not correlate with a lower patient satisfaction score compared with the other procedure groups. These ﬁndings are also consistent with those from other published studies who have questioned the use of joint implants for the ﬁrst MTPJ (38–45). Within the resectional arthroplasty group, we observed “ﬂoating hallux,” which occurred in 30.9% of the cases, with lesser metatarsalgia in 14.5% of the cases. These rates are lower than from other published reports, which have reported up to 79% of postoperative ﬂoating toe and 57.9% complaining of metatarsalgia (46–48). Beertema et al (25) retrospectively compared the long-term outcome (mean of 7 years) of 74 patients who underwent cheilectomy, resectional arthroplasty, or arthrodesis. They reported that resectional arthroplasty yielded better results in earlier stages of hallux rigidus than did arthrodesis. Additionally, 33% of subjects reported a limited walking distance in the arthrodesis group compared with 14% of the subjects in the resectional arthroplasty group reporting a limited walking distance. This is in contrast to a prospective, randomized study by O’Doherty et al (26), which compared resectional arthroplasty versus arthrodesis in 82 subjects with a follow-up of at least 2 years. They reported no difference in patient satisfaction, relief of pain, improvement in walking distance, or reduction in footwear problems between the 2 groups. They went on to recommend resectional arthroplasty in older patients with hallux rigidus because of its technical simplicity. Our results indicate that age was not a factor in procedure selection and did not negatively affect patient satisfaction. Gibson and Thomason (49) published a prospective, randomized, controlled trial directly comparing the outcomes between implant arthroplasty and arthrodesis. A total of 63 patients with end-stage hallux rigidus were randomized into an arthrodesis group (circlage wire and pinning) or an implant arthroplasty group (unconstrained 2-component system). Pain, function, radiographic alignment, patient satisfaction, clinical changes, and adverse events were measured. At 12 and 24 months, the arthrodesis group was superior to the implant
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
arthroplasty group with respect to pain, function, and alignment. The cost of the arthrodesis was also reported as lower. However, there are signiﬁcant issues with their study. For example, the randomization was marred by bilateral assignment. Furthermore, the patients were not accounted for in all measurements. There are other important considerations as well. The ﬁrst is that signiﬁcant pain relief was reported in both groups at the 2-year follow-up period. Ultimately, pain relief is the goal for any joint destructive procedure. That study clearly demonstrated that implant arthroplasty signiﬁcantly decreased pain. Second, the cost analysis might not be accurate because screw and/or plate ﬁxation is the most predominant type of ﬁxation currently in use for ﬁrst MTPJ fusions. Therefore, these costs would be greater than the circlage wire and pin ﬁxation used in their study (26). We did not perform a cost analysis and hence cannot conclude that any of the 3 procedures performed is more or less costly. Cost is a consideration in procedure selection (50). This is certainly true if the outcome of 1 procedure was clearly inferior to another. The results from our study did not reveal any statistically signiﬁcant difference in the patient satisfaction scores between the arthrodesis group and hemi-implant group. Raikin et al (51) published a retrospective study involving 46 subjects who had undergone either hemi-metallic implant arthroplasty or joint fusion. All hemi-implant arthroplasties were performed by 1 surgeon and the fusions, using 2-crossed screws, were performed by another surgeon. The investigators concluded that arthrodesis of the ﬁrst MTPJ was more predictable for reduction of pain and restoring function than the implant arthroplasty group. However, both groups reported a decrease in pain. Again, this is in contrast to our results, which showed no difference in patient outcome scores between hemi-metallic implant arthroplasty and arthrodesis. Maffulli et al (52) conducted a quantitative, systematic literature review of surgical procedures for the treatment of hallux rigidus, including arthrodesis, hemi-implant arthroplasty, and resectional arthroplasty. They concluded that “the heterogeneity in terms of study design, length of follow-up, classiﬁcation grading systems, radiological and clinical ﬁndings did not allow [us] to compare extracted data.” Despite those limitations, they found that the 3 procedures examined in our study had comparable reported success rates in the published data they reviewed. In our study, we used the same classiﬁcation system, the subjective outcome scoring scale, and radiographic and clinical parameters. We also came to the same conclusion that the results are comparable, regardless of the selected procedure. Our study had several limitations. First, the retrospective nature of our study design did not allow for preoperative (baseline) score comparisons or pre- versus postoperative score comparisons. Therefore, it is possible that the preoperative scores could have been lower for 1 group versus another. This could have skewed the results in favor of 1 procedure over another. However, because we found no difference in the subjective post-operative outcome scores among the 3 procedures, the use of preoperative scores does not appear to be as relevant. If differences had been found in the postoperative scores among the 3 procedures, then certainly the initial preoperative scores could have biased the results. Furthermore, we cannot conclude anything regarding the degree of improvement from preoperatively to postoperatively. Again, this is a signiﬁcant limitation for a retrospective study design. Second, the surgical technique was not standardized for any of the 3 procedures. Owing to the retrospective, multicenter study design, procedure standardization would have been impossible. Our study reﬂects a more “real world” design in which there are differences in surgical technique between surgeons and geographic location. Despite the differences in the surgical technique used from surgeon to surgeon, the long-term outcomes of pain, function, and alignment/appearance were not signiﬁcantly
different statistically, regardless of the surgical procedure selected. Finally, procedure selection bias might have inﬂuenced the results. A surgeon might have selected a particular procedure according to the patient’s individual expectations, the surgeon’s experience with a particular procedure, and multiple other factors. This bias is inherent to a multicenter/multisurgeon study design and cannot be entirely circumvented. Again, we believe that the results of the present study allows for a greater degree of generalizability and applicability, because our results showed no difference in the outcome scores despite the factors that might have differed from patient to patient and surgeon to surgeon. Conclusion The results of our study indicate similar long-term patient satisfaction scores for treatment of end-stage hallux rigidus with arthrodesis, hemi-implant arthroplasty, and resectional arthroplasty. Furthermore, procedure selection does not appear to be related to the age of the patient. The surgeon should also discuss the commonly occurring long-term ﬁndings of each selected procedure with the patient. There are multiple factors involved in the selection of the most appropriate procedure for the treatment of end-stage hallux rigidus. The bone quality, ambulatory and physical demands, desires of the patient for joint motion, and surgeon experience and knowledge of outcomes, all play a critical role in proper procedure selection. Acknowledgment We acknowledge Kim Cooper, PhD, at Midwestern University, Glendale Arizona for his statistical analysis and support. References 1. Grady JF, Axe TM, Zager EJ, Sheldon LA. A retrospective analysis of 772 patients with hallux limitus. J Am Podiatr Med Assoc 92:102–108, 2002. 2. Coughlin MJ, Shurnas PS. Hallux rigidus: demographics, etiology, and radiographic assessment. Foot Ankle Int 24:731–743, 2003. 3. Bouaicha S, Ehrmann C, Moor BK, Maquieira GJ, Espinosa N. Radiographic analysis of metatarsus primus elevatus and hallux rigidus. Foot Ankle Int 31:807–814, 2010. 4. Flavin R, Halpin T, O’Sullivan R, FitzPatrick D, Ivankovic A, Stephens MM. A ﬁniteelement analysis study of the metatarsophalangeal joint of the hallux rigidus. J Bone Joint Surg Br 90:1334–1340, 2008. 5. Beeson P, Phillips C, Corr S, Ribbans WJ. Hallux rigidus: a cross-sectional study to evaluate clinical parameters. Foot (Edinb) 19:80–92, 2009. 6. Shurnas PS. Hallux rigidus: etiology, biomechanics, and nonoperative treatment. Foot Ankle Clin 14:1–8, 2009. 7. Beeson P, Phillips C, Corr S, Ribbans W. Classiﬁcation systems for hallux rigidus: a review of the literature. Foot Ankle Int 29:407–414, 2008. 8. Coughlin MJ, Shurnas PS. Hallux rigidus: grading and long-term results of operative treatment. J Bone Joint Surg Am 85-A:2072–2088, 2003. 9. Keiserman LS, Sammarco VJ, Sammarco GJ. Surgical treatment of the hallux rigidus. Foot Ankle Clin 10:75–96, 2005. 10. Vanore JV, Christensen JC, Kravitz SR, Schuberth JM, Thomas JL, Weil LS, Zlotoff HJ, Mendicino RW, Couture SD. Diagnosis and treatment of ﬁrst metatarsophalangeal joint disorders. Section 2: hallux rigidus. J Foot Ankle Surg 42:124–136, 2003. 11. Brage ME, Ball ST. Surgical options for salvage of end-stage hallux rigidus. Foot Ankle Clin 7:49–73, 2002. 12. Broca P. Deformities of the anterior foot caused by various types of shoes. Bull Soc Anat 27:60–67, 1852. 13. McKeever DC. Arthrodesis of the ﬁrst metatarsophalangeal joint for hallux valgus, hallux rigidus, and metatarsus primus varus. J Bone Joint Surg Am 34-A:129–134,1952. 14. Kumar S, Pradhan R, Rosenfeld PF. First metatarsophalangeal arthrodesis using a dorsal plate and a compression screw. Foot Ankle Int 31:797–801, 2010. 15. Wassink S, van den Oever M. Arthrodesis of the ﬁrst metatarsophalangeal joint using a single screw: retrospective analysis of 109 feet. J Foot Ankle Surg 48:653– 661, 2009. 16. Maher AJ, Metcalfe SA. First MTP joint arthrodesis for the treatment of hallux rigidus: results of 29 consecutive cases using the foot health status questionnaire validated measurement tool. Foot (Edinb) 18:123–130, 2008. 17. Coughlin MJ, Mann RA. Arthrodesis of the ﬁrst metatarsophalangeal joint as salvage for the failed Keller procedure. J Bone Joint Surg Am 69:68–75, 1987. 18. Machacek F Jr, Easley ME, Gruber F, Ritschl P, Trnka HJ. Salvage of a failed Keller resection arthroplasty. J Bone Joint Surg Am 86-A:1131–1138, 2004.
P.J. Kim et al. / The Journal of Foot & Ankle Surgery xxx (2011) 1–7
19. Vienne P, Sukthankar A, Favre P, Werner CM, Baumer A, Zingg PO. Metatarsophalangeal joint arthrodesis after failed Keller-Brandes procedure. Foot Ankle Int 27:894–901, 2006. 20. Swanson AB, Lumsden RM, Swanson GD. Silicone implant arthroplasty of the great toe: a review of single stem and ﬂexible hinge implants. Clin Orthop Relat Res 142:30–43, 1979. 21. Giza E, Sullivan M, Ocel D, Lundeen G, Mitchell M, Frizzell L. First metatarsophalangeal hemiarthroplasty for hallux rigidus. Int Orthop 34:1193–1198, 2010. 22. Konkel KF, Menger AG, Retzlaff SA. Results of metallic hemi-great toe implant for grade iii and early grade iv hallux rigidus. Foot Ankle Int 30:653–660, 2009. 23. Sorbie C, Saunders GA. Hemiarthroplasty in the treatment of hallux rigidus. Foot Ankle Int 29:273–281, 2008. 24. Keller W. The surgical treatment of bunions and hallux valgus. NY Med J 80:741– 742, 1904. 25. Beertema W, Draijer WF, van Os JJ, Pilot P. A retrospective analysis of surgical treatment in patients with symptomatic hallux rigidus: long-term follow-up. J Foot Ankle Surg 45:244–251, 2006. 26. O’Doherty DP, Lowrie IG, Magnussen PA, Gregg PJ. The management of the painful ﬁrst metatarsophalangeal joint in the older patient: arthrodesis or Keller’s arthroplasty? J Bone Joint Surg Br 72:839–842, 1990. 27. Hamilton WG, O’Malley MJ, Thompson FM, Kovatis PE. Roger Mann Award 1995: capsular interposition arthroplasty for severe hallux rigidus. Foot Ankle Int 18:68– 70, 1997. 28. Sherman KP, Douglas DL, Benson MK. Keller’s arthroplasty: is distraction useful? A prospective trial. J Bone Joint Surg Br 66:765–769, 1984. 29. Hahn MP, Gerhardt N, Thordarson DB. Medial capsular interpositional arthroplasty for severe hallux rigidus. Foot Ankle Int 30:494–499, 2009. 30. Zlotoff HJ, Christensen JC, Mendicino RW, Schuberth JM, Schwartz NH, Thomas JL, et al. ACFAS Universal Foot and Ankle Scoring System: First Metatarsophalangeal Joint and First Ray (module 1). J Foot Ankle Surg 41:2–5, 2002. 31. Cook JJ, Cook EA, Rosenblum BI, Landsman AS, Roukis TS. Validation of the American College of Foot and Ankle Surgeons scoring scales. J Foot Ankle Surg 50:420–429, 2011. 32. Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int 15:349–353, 1994. 33. Roukis TS, Jacobs PM, Dawson DM, Erdmann BB, Ringstrom JB. A prospective comparison of clinical, radiographic, and intraoperative features of hallux rigidus: short-term follow-up and analysis. J Foot Ankle Surg 41:158–165, 2002. 34. Bennett GL, Kay DB, Sabatta J. First metatarsophalangeal joint arthrodesis: an evaluation of hardware failure. Foot Ankle Int 26:593–596, 2005. 35. Bennett GL, Sabetta J. First metatarsalphalangeal joint arthrodesis: evaluation of plate and screw ﬁxation. Foot Ankle Int 30:752–757, 2009.
36. Goucher NR, Coughlin MJ. Hallux metatarsophalangeal joint arthrodesis using dome-shaped reamers and dorsal plate ﬁxation: a prospective study. Foot Ankle Int 27:869–876, 2006. 37. Ellington JK, Jones CP, Cohen BE, Davis WH, Nickisch F, Anderson RB. Review of 107 hallux MTP joint arthrodesis using dome-shaped reamers and a stainless-steel dorsal plate. Foot Ankle Int 31:385–390, 2010. 38. Ess P, Hamalainen M, Leppilahti J. Non-constrained titanium-polyethylene total endoprosthesis in the treatment of hallux rigidus: a prospective clinical 2-year follow-up study. Scand J Surg 91:202–207, 2002. 39. Freed JB. The increasing recognition of medullary lysis, cortical osteophytic proliferation, and fragmentation of implanted silicone polymer implants. J Foot Ankle Surg 32:171–179, 1993. 40. Fuhrmann RA, Wagner A, Anders JO. First metatarsophalangeal joint replacement: the method of choice for end-stage hallux rigidus? Foot Ankle Clin 8:711–721, 2003. vi. 41. Konkel KF, Menger AG. Mid-term results of titanium hemi-great toe implants. Foot Ankle Int 27:922–929, 2006. 42. Mondul M, Jacobs PM, Caneva RG, Crowhurst JA, Morehead DE. Implant arthroplasty of the ﬁrst metatarsophalangeal joint: a 12-year retrospective study. J Foot Surg 24:275–279, 1985. 43. Papagelopoulos PJ, Kitaoka HB, Ilstrup DM. Survivorship analysis of implant arthroplasty for the ﬁrst metatarsophalangeal joint. Clin Orthop Relat Res 302:164–172, 1994. 44. Pulavarti RS, McVie JL, Tulloch CJ. First metatarsophalangeal joint replacement using the bio-action great toe implant: intermediate results. Foot Ankle Int 26:1033–1037, 2005. 45. Vanore J, O’Keefe R, Pikscher I. Silastic implant arthroplasty: complications and their classiﬁcation. J Am Podiatr Assoc 74:423–433, 1984. 46. Schenk S, Meizer R, Kramer R, Aigner N, Landsiedl F, Steinboeck G. Resection arthroplasty with and without capsular interposition for treatment of severe hallux rigidus. Int Orthop 33:145–150, 2009. 47. Ozan F, Bora OA, Filiz MA, Kement Z. Interposition arthroplasty in the treatment of hallux rigidus. Acta Orthop Traumatol Turc 44:143–151, 2010. 48. Love TR, Whynot AS, Farine I, Lavoie M, Hunt L, Gross A. Keller arthroplasty: a prospective review. Foot Ankle 8:46–54, 1987. 49. Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int 26:680–690, 2005. 50. Hyer CF, Glover JP, Berlet GC, Lee TH. Cost comparison of crossed screws versus dorsal plate construct for ﬁrst metatarsophalangeal joint arthrodesis. J Foot Ankle Surg 47:13–18, 2008. 51. Raikin SM, Ahmad J, Pour AE, Abidi N. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. J Bone Joint Surg Am 89:1979–1985, 2007. 52. Maffulli N, Papalia R, Palumbo A, Del Buono A, Denaro V. Quantitative review of operative management of hallux rigidus. Br Med Bull Epub, 2011 Jan 14.