Isolated Talonavicular Arthrodesis as Treatment for Flexible Progressive Collapsing Foot Deformity: A Case Series.

Background: For the younger, more active patient with flexible symptomatic progressive collapsing foot deformity (PCFD), joint-sparing procedures may be preferred to preserve functional motion. Isolated talonavicular (TN) arthrodesis has been described for treatment of rigid and flexible PCFD for patients that are older and less active whose deformity is still correctable through the TN joint. The purpose of this study was to evaluate radiographic and clinical outcomes in patients with PCFD treated with isolated triplanar correction with a TN joint arthrodesis. Methods: Forty-nine patients (53 feet) with flexible PCFD underwent isolated TN arthrodesis. Weightbearing radiographs were performed pre- and postoperatively, and measurements included lateral talar-first metatarsal angle, calcaneal pitch, TN coverage angle, and the anteroposterior (AP) talar-first metatarsal angle. The Foot and Ankle Ability Measure (FAAM) and Veterans-Rand 12-Item Health Survey (VR-12) scores were also collected. Results: Thirty-five females and 14 males were evaluated with a mean age of 63 years, at an average follow-up of 41.3 months. Significant improvements were found radiographically. Lateral radiographs demonstrated improvements in lateral talar-first metatarsal angle from 25.2 degrees preoperatively to 9.5 degrees postoperatively (P < .001) and calcaneal pitch from 14.9 degrees preoperatively to 17.5 degrees postoperatively (P < .001). AP radiographs showed the TN coverage angle improving from 35.0 degrees to 4.9 degrees postoperatively (P < .001) and AP talar-first metatarsal angle improving from 17.3 degrees to 5.9 degrees postoperatively (P < .001). Clinical outcomes were improved in the FAAM pain score (48.6 to 39.2, P = .130), FAAM ADL score (53.8 to 69.2, P = .002), FAAM Sport score (29.5 to 40.7, P = .099), and the overall FAAM score (47.7 to 63.1, P = .006). Patient satisfaction with medical care was 85.2/100 postoperatively. Conclusion: Isolated TN arthrodesis is a viable surgical option for older, lower-demand patients with flexible PCFD. This study demonstrated significant improvements in radiographic alignment and FAAM scores. Comparative studies with other surgical procedures should be performed to determine which is the best technique for older, lower-demand patients with flexible PCFD. Level of Evidence: Level III, retrospective cohort study.

Outcomes of Conversion of Ankle Fusion to Total Ankle Arthroplasty.

With ankle replacements gaining popularity and documented good functional outcomes, there is an increasing number of patients inquiring about the possibility of converting an ankle fusion to a replacement. This could be due to pain, limited function, or increasing adjacent joint arthritis. There is an increasing body of evidence in the literature that a conversion to a replacement is possible and that the outcomes are positive. There are also absolute contradictions for a conversion. An absent fibula, pain of unknown origin, and recent infection fall in this category. Long-term follow-up is needed to see if conversions of ankle fusions to replacements have the same functional results and longevity as primary replacements.

Prospective Multicenter Study of Salto Talaris Ankle Arthroplasty With Minimum 4-Year Follow-Up.

BACKGROUND: Total ankle arthroplasty (TAA) continues to be investigated as a primary treatment for end-stage ankle arthritis. The objective of this study is to report mid- to long-term results of the Salto Talaris TAA using prospectively collected patient-reported outcomes and implant survival rates with 4- to 13-year follow-up. METHODS: This was a retrospective study of prospectively collected data from 2 multicenter cohort studies from 3 centers. Three hundred fourteen subjects who received a Salto Talaris TAA from 2005 to 2015 were included in the study. Follow-up ranged 4-13 years following index procedure. Outcomes included 36-Item Short Form Health Survey (SF-36) mental and physical component summary scores, pain scores, and adverse events including additional surgeries, revision, or removal of components. RESULTS: Significant improvements were seen in pain and physical function scores at 2-year follow-up and were generally maintained through most recent follow-up. The survival rate of the prosthesis was >95% (n = 30/32 at >10 years, n = 272/282 at 4.5-10 years). Thirteen patients (4.1%) underwent revision or removal of their prosthesis. Time to revision ranged from 2 months to 6.5 years following the index procedure. Twenty-two patients (7.0%) had additional surgery that did not involve revision or removal of components. CONCLUSION: Treatment of end-stage ankle arthritis with this implant provided patients with improved pain and functional outcome scores at mid- to long-term follow-up. The significant improvements reported at 2-4 years appeared to endure through the extended follow-up period. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device.

Percutaneous tibial neuromodulation is a medical guideline recommended therapy for treating symptoms of overactive bladder. Stimulation is delivered to the tibial nerve via a thin needle placed percutaneously for 30 min once a week for 12-weeks, and monthly thereafter. Studies have shown that this therapy can effectively relieve symptoms of overactive bladder; however, the frequent office visits present a barrier to patients and can impact therapy effectiveness. To mitigate the burden of frequent clinic visits, small implantable devices are being developed to deliver tibial neuromodulation. These devices are implanted during a single minimally invasive procedure and deliver stimulation intermittently, similar to percutaneous tibial neuromodulation. Here, we describe the implant procedure and design of a pivotal study evaluating the safety and effectiveness for an implantable tibial neuromodulation device. The Evaluation of Implantable Tibial Neuromodulation (TITAN 2) pivotal study is a prospective, multicenter, investigational device exemption study being conducted at up to 30 sites in the United States and enrolling subjects with symptoms of overactive bladder.

Outcomes of Surgically Treated Purely Ligamentous Stage II Lisfranc Injuries.

BACKGROUND: Low-energy stage II Lisfranc injuries are rare, and treatment can be operative or nonoperative based on a surgeon's assessment of midfoot stability. No previously published patient-reported outcome measures (PROMs) data for Lisfranc injuries isolates purely ligamentous stage II injuries. The purpose of this study was to analyze PROMs for patients who underwent operative management of stage II Lisfranc injuries. METHODS: Thirty-nine patients (39 feet) with confirmed Nunley-Vertullo stage II Lisfranc injuries between May 2012 and February 2022 were identified through a retrospective chart review. PROMs that were analyzed were the visual analog scale (VAS) pain scale, Veterans RAND 12-Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), and patient satisfaction. RESULTS: Thirty-two open reduction internal fixations (ORIFs) and 7 fusions were performed. The mean latest follow-up was 44.6 (range, 12-92) months. There were 2 complications (5%, 2/39) that required a revision procedure. Twenty-six patients (67%, 26/39) underwent secondary surgery to remove retained hardware. The mean time to hardware removal was 3.97 (range, 2.70-7.47) months. The overall mean patient satisfaction score with overall medical care including clinical visits and interactions with medical staff personnel was 93.6/100. All PROMs (VAS, VR-12, FAAM) demonstrated statistically significant improvement (P < .05) from preoperative (injury) values to latest follow-up postinjury values. CONCLUSION: Patients who were treated surgically with stage II purely ligamentous Lisfranc injuries via the methods used were found to mostly undergo hardware removal and have high levels of overall satisfaction with their process of medical care. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Takedown of Ankle Fusions and Conversion to Total Ankle Replacements.

BACKGROUND: With ankle replacements gaining credibility, there is a small subset of patients who might benefit from a conversion of an ankle fusion to a replacement. The objective of this study is to present clinical and radiographic results of patients who had their ankle fusion converted to total ankle arthroplasty (TAA). METHODS: Patients presented to the senior author with ongoing ankle pain following fusion or increasing pain after a period of relative comfort after an ankle fusion. Outcomes were evaluated preoperatively and postoperatively with the Veterans Rand Health Survey (VR-12), Ankle Osteoarthritis Scale (AOS), and visual analog scale (VAS) pain scale. A patient satisfaction survey was also distributed. RESULTS: All ankle fusion conversions between April 2010 and December 2019 were included. Fifty-one patients (30 females) with the mean age of 62.6 (range, 37-83) years were followed. Mean follow-up was 4.2±2.3 (range, 2-11.5) years. Two patients were lost to follow-up (1 is deceased). Pre- and postoperative mean patient-reported outcome scores were all significantly different between groups except VR-12 mental subscale scores. VR-12 physical scores improved from 28.7±8.9 preoperatively to 38.9±9.9 (P < .001) postoperatively; VR-12 mental score was stable. AOS pain and disability subscales similarly improved: 55.9±24.4 to 27.9±25.4 (P < .001) and 61.7±21.1 to 31.1±25.7 (P < .001), respectively. VAS pain improved from a mean of 64.5±27.3 to 29.4±27.7 (P < .001). There was no tibiotalar dorsiflexion or plantarflexion with the ankle fusion. Initial postoperative visit revealed that average dorsiflexion was 10.9±5.93 degrees and average plantarflexion was 14.1±5.22 degrees. At the latest follow-up, dorsiflexion improved significantly to 15.5±6.33 degrees (P < .001), with no significant improvement in plantarflexion (P = .980). CONCLUSION: In this single-surgeon longitudinal study of 51 patients with a painful, malaligned, or nonhealed ankle fusion treated with an ankle replacement, we found highly satisfactory functional outcomes at an average of 4.2 years. Continued long-term follow-up will reveal whether the longevity of these replacements is comparable to primary replacements.

Comparing 4-Year Changes in Patient-Reported Outcomes Following Ankle Arthroplasty and Arthrodesis.

BACKGROUND: The rate of total ankle arthroplasty (TAA) is increasing relative to ankle arthrodesis (AA) for patients seeking surgical treatment for end-stage ankle arthritis. Patients and providers would benefit from a more complete understanding of the rate of improvement, the average length of time to achieve maximal function and minimal pain, and whether there is a greater decline in function or an increase in pain over time following TAA compared with AA. The objectives of this study were to compare treatment changes in overall physical and mental function and ankle-specific function, as well as pain intensity at 48 months after TAA or AA in order to determine if the improvements are sustained. METHODS: This was a multisite prospective cohort study that included 517 participants (414 TAA and 103 AA) who presented for surgical treatment. Participants were compared 48 months after surgery using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sports subscales (0 to 100 points), the Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) scores (0 to 100 points), and pain scores (0 to 10 points). RESULTS: Both groups achieved significant improvement in the 2 FAAM measures, the SF-36 PCS score, and all of the pain measures at 48 months after surgey (p < 0.001). Mean improvements from baseline in patients undergoing TAA for the FAAM Activities of Daily Living, FAAM Sports, and SF-36 scores were at least 9 points, 8 points, and 3.5 points, respectively, which were higher than in those undergoing AA. Mean improvements in worst and average pain were at least 0.9 point higher in patients undergoing TAA than in those undergoing AA at 12, 24, and 36 months. These differences were attenuated by 48 months. For both treatments, all improvements from baseline to 24 months had been maintained at 48 months. CONCLUSIONS: When both procedures are performed by the same group of surgeons, patients who undergo TAA or AA for end-stage ankle arthritis have significant improvement in overall function, ankle-specific function, and pain at 48 months after surgery, with better functional improvement in the TAA group. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Converting Ankle Arthrodesis to a Total Ankle Arthroplasty.

Several articles in the literature discuss the positive results of converting a painful ankle fusion to an ankle replacement. Our results confirm that in well-selected cases a conversion to a total ankle replacement is not only possible, but also significantly improves quality of life and reduces pain. The outcome of a total ankle replacement after an ankle fusion depends to a degree on the method of fusion. Less destructive fusion that is arthroscopic has better results than conventional transfibular open fusions. Absence of a fibula should be an absolute contraindication for a conversion.

Femoral Head Allografts for Talar Body Defects.

BACKGROUND: Large structural bone deficits after a failed ankle arthroplasty or avascular necrosis (AVN) of the talus present a complex reconstruction challenge. The aim of this study was to report the results of patients undergoing an ankle arthrodesis or tibiotalocalcaneal fusion using a femoral head allograft (FHA). METHODS: All ankle and tibiotalocalcaneal fusions using FHA between February 2006 and January 2019 were included. Forty-four patients (45 ankles) with a mean follow-up of 42.8 months were studied. Males accounted for 58.1% (25/43 patients). All patients had either failure of primary or revision total ankle arthroplasty (TAA) or AVN of the talus. Pre- and postoperative Veterans RAND Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), Ankle Osteoarthritis Scale (AOS) and visual analog scale (VAS) for pain scores were obtained. A patient satisfaction survey was distributed postoperatively and results were tabulated. RESULTS: Preoperatively to postoperatively, the VR-12 Mental score remained essentially unchanged (P = .752) and the VR-12 Physical score improved (P = .007); the FAAM Activities of Daily Living (ADL) and Sport scores improved (P < .001); the AOS Pain and Disability scores improved (P < .001); and the man VAS score improved (P < .001). The overall satisfaction rate was 78.6 on a 100-point scale. At an average of 18.7 weeks, 90.7% of the ankles were substantially fused. Five patients went on to nonunions and revision surgery. CONCLUSION: The use of FHA to treat talar defects was a viable option. In this complex patient population, the arthrodesis rate was high at 89% with very positive patient-reported outcome scores. LEVEL OF EVIDENCE: Level IV, case series.

Traditional Modified Broström vs Suture Tape Ligament Augmentation.

BACKGROUND: The modified Broström (MB) procedure has long been the mainstay for the treatment of chronic lateral ankle instability (CLAI). Recently, suture tape (ST) has emerged as augmentation for this repair. The clinical benefit of such augmentation has yet to be fully established. The purpose of this study was to determine if ST augmentation provides an advantage over the traditional MB. METHODS: Adult patients were identified for inclusion in the study based on indications for primary lateral ligament reconstruction for CLAI. The primary outcome measure was time to return to preinjury level of activity (RTPAL). Secondary outcome measures included complications, ability to participate in an accelerated rehabilitation protocol (ARP), patient-reported outcomes (PROs), and visual analog pain scale (VAS). A total of 119 patients with CLAI were enrolled and randomized to the MB (59 patients) or ST (60 patients) treatment arm. RESULTS: Average RTPAL was 17.5 weeks after MB and 13.3 weeks after ST (P < .001). At 26 weeks, 12.5% of patients in the MB group and 3.6% of patients in the ST group had not managed RTPAL (P = .14). The complication rate was 8.5% in the MB group vs 1.7% in the ST group (P = .12). Four patients in the MB group failed to complete the ARP vs 1 in the ST group (P = .144). CONCLUSION: Results from this multicenter, prospective, randomized trial suggest that ST augmentation allows for earlier RTPAL than MB alone. ST augmentation may support successful accelerated rehabilitation and did not result in increased complications or morbidity. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Functional Outcome of Sesamoid Excision in Athletes.

BACKGROUND: Sesamoid injuries can have a significant effect on the ability of athletes to return to play. The literature shows mixed results with sesamoid excisions and the ability to return to sports. HYPOTHESIS/PURPOSE: The purpose was to describe patient-reported outcomes and return to sports in athletes after sesamoidectomy with a proper surgical technique and a well-structured rehabilitation protocol. It was hypothesized that sesamoid excision would demonstrate reproducible and encouraging long-term patient outcomes. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: All patients from a single surgeon's practice who underwent sesamoidectomy between January 2006 and September 2015 were identified. Medial sesamoids were excised through a medial approach, and lateral sesamoids were excised through a plantar approach. The plantar structures were adequately repaired after excision. The Foot Function Index-Revised (FFI-R), 12-Item Short Form Health Survey (SF-12), and visual analog scale (VAS) were collected preoperatively and at subsequent follow-up appointments. A patient satisfaction survey and Single Assessment Numeric Evaluation (SANE) questionnaire were also collected. Athletes were defined as those who participated in sports at a high school level or higher. RESULTS: Of the 108 feet that met the inclusion criteria, 26 werelost to follow-up, leaving 82 feet for analysis at a mean 31.3 ± 26.0 months. There were 72 female patients and 10 male patients included in the final analysis, with a mean age of 44.9 ± 20.2 years. There were 54 medial, 18 lateral, and 10 medial and lateral sesamoid excisions. There were 26 competitive athletes with follow-up appointments (dancer, n = 12; pivot sport athlete, n = 8; runner, n = 6). Both the entire study population and the athletes demonstrated a significant improvement in SF-12, SANE, VAS, and FFI-R cumulative at the latest available follow-up (P < .05). Among the athletes, 80% were able to return to competitive sports at a mean 4.62 ± 1.01 months after surgery. The median satisfaction score among all patients was 97.5%. There was no difference in the success rate between the different etiologies at any of the follow-up intervals. CONCLUSION: Chronic sesamoid pain is difficult to treat, but this study confirms that with a meticulous surgical technique and a dedicated postoperative rehabilitation program, encouraging patient-reported outcomes can be expected with a minimal risk of complications. Moreover, in the current study, 80% of competitive athletes were able to return to sports at a mean of 4.62 months after surgery.

Surgical Outcomes of Os Trigonum Syndrome in Dancers: A Case Series.

BACKGROUND: Management of ankle pain in dancers can be challenging because of the repetitive stress and complex demands placed on this region. Despite the prevalence of ankle injuries in this population, literature on surgical outcomes and return to dance is limited. PURPOSE: To retrospectively evaluate the efficacy and functional outcomes after surgical excision of a symptomatic os trigonum in dancers. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Between June 2006 and June 2016, a total of 44 dancers underwent surgical excision of a symptomatic os trigonum at a single institution and by a single surgeon. All patients presented with symptoms of posterior ankle impingement syndrome and subsequently failed nonsurgical treatment. Clinical analysis was conducted using various pre- and postoperative patient-reported outcome questionnaires, including the Veterans RAND 12-Item Health Survey (VR-12), Foot Function Index-Revised (FFI-R), and visual analog scale (VAS) for pain, as well as subjective patient satisfaction. RESULTS: A total of 44 patients (54 ankles; mean age, 18.2 years) were retrospectively evaluated at a mean follow-up of 33.4 months. The VR-12 Physical Health score improved from a mean score of 37.8 ± 11.9 to 51.2 ± 10.5 (P < .001). The cumulative FFI-R score improved from 46.45 ± 13.8 to 31.2 ± 9.7 (P = .044), with the subcategory of "activity limitation" representing the highest-scoring FFI-R subcategory at 65.28 ± 13.4 preoperatively and improving to 34.47 ± 12.4 at follow-up (P < .001). The mean VAS score for subjective pain improved significantly from 5.39 ± 2.84 to 1.73 ± 2.10 (P < .00044). CONCLUSION: Overall, the findings of the present study demonstrate that dancers of varying style and level improved significantly according to various clinical measures. Patients included in this study reported that they returned to their previous level of dance upon completion of physical therapy and maintained thriving postoperative careers, which for several meant dancing at the professional level.

Management of Ankle Arthritis After Severe Ankle Trauma.

OBJECTIVES: There are still unanswered questions about the best treatment options for ankle arthritis after severe lower leg trauma. This study compared results in outcomes and complications for 3 groups. DESIGN: Retrospective cohort study case-control study. SETTING: Single institution. PATIENTS: Three groups of 100 surgeries. INTERVENTION: Patients underwent an ankle fusion using anterior plate, total ankle arthroplasty (TAA) for primary osteoarthritis (OA), or a TAA for post-traumatic arthritis (PTA). MAIN OUTCOME MEASUREMENTS: Veterans Rand 12-Item Health Survey (VR-12), Ankle Osteoarthritis Scale, Visual Analog Pain Scale, and the American Orthopaedic Foot and Ankle Society Hindfoot score were collected preoperatively and at subsequent postoperative appointments. A patient satisfaction survey was also distributed to each patient postoperatively. RESULTS: Although all scores improved from preoperative to latest postoperative, the total ankle for PTA consistently resulted in the best postoperative outcomes. Patient satisfaction survey indicated 26% of fusion, 55% of TAA-OA, and 63% of TAA-PTA experienced very good to excellent pain relief. The overall satisfaction was found to be 92.5% for the TAA-PTA patients, 90.5% for the TAA-OA patients, and 84% for the fusion patients. Revision surgeries included 2 from the TAA-OA group, 2 from the TAA-PTA group, and 1 fusion patient. CONCLUSIONS: Results of comparing 3 groups who underwent an ankle fusion or a TAA demonstrate improvement in pain (P < 0.001), physical quality of life (P < 0.001), and activity (P < 0.001) and resulted in a high level of patient satisfaction. LEVEL OF EVIDENCE: Level III. See Instructions for Authors for a complete description of levels of evidence.

Patient-Reported Outcomes and Early Complications After Synthetic Cartilage Device Implantation.

BACKGROUND: Previous Level I studies show promising results for the use of a hydrogel synthetic cartilage implant (SCI) for the treatment of hallux rigidus. A recent independent retrospective review has put those results into question, however. The purpose of this article is to report patient-reported outcomes and early complications using this implant so as to add to the paucity of data in the literature regarding this implant. METHODS: This was a retrospective chart review of patients undergoing hydrogel synthetic cartilage implant for the treatment of hallux rigidus from July 2017 to November 2018. Data collected included patient demographics, radiographic grading, and outcomes: Veterans Rand 12 Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), visual analog scale (VAS), patient satisfaction, and complications. Fifty-four patients (59 feet) with an average age of 57.6 (range, 39-78) years were analyzed. The average latest follow-up was 18.9 (range, 3-31.3) months. Body mass index was 26.7 (range, 18.7-35.2). None were diabetic and 5 were smokers. RESULTS: The mean outcome improvements were 6.5 points (VR-12 Physical), 17.2 points (FAAM ADL), 27.4 points (FAAM Sport), and 18.4 points (VAS) (P < .01 for each). Scores were significantly improved from preoperatively to most recent follow-up for FAAM ADL (71.0 vs 88.2 points), FAAM Sports (44.6 vs 72.0 points), and VAS (49.4 vs 31.0) (P < .01). Overall, 72.5% patients would definitely or probably have the operation again. Ten patients (18.5%) went on to have revision surgery. Of these, 7 patients were revised to an arthrodesis, and 1 metal hemiarthroplasty and 2 implants were removed because of infection. CONCLUSION: Synthetic cartilage implantation for the treatment of hallux rigidus demonstrated improved pain and outcome scores at short-term follow-up. Reoperation and conversion to fusion rates were comparable to prior studies. LEVEL OF EVIDENCE: Level IV, case series.

Outcomes of Nitinol Compression Staples in Tarsometatarsal Fusion.

BACKGROUND: Tarsometatarsal (TMT) arthrodesis is commonly performed in the management of midfoot arthritis, trauma, or deformity. The purpose of this study was to collect aggregate data (demographic, surgical, and perioperative outcomes) on patients who previously had a TMT fusion with BME compression staples. METHODS: Sixty-six patients underwent TMT fusion with BME compression staples. Outcomes included demographics, surgical information, the Veterans Rand VR-12 Health Survey, Foot and Ankle Ability Measure (FAAM), visual analog scale (VAS), Revised-Foot Function Index (FFI-R), Ankle Osteoarthritis Scale (AOS), patient satisfaction survey scores, radiographic fusion rate, level of pain reduction, and complications. Sixty-six patients (68 feet) were analyzed (59 females) with an average age of 64 years (range, 18-83). The mean latest follow-up was 35.9 (range, 6-56.6 months). RESULTS: The average surgical time was 38.1±14.3 minutes (range, 11-75). All outcomes improved significantly (P < .001) from preoperative to latest follow-up except for the VR-12 Mental and Physical score. The average time to fusion determined by radiographs was 8.4 weeks (range, 6.1-46.1 weeks). Wound complications were not seen. Indications for subsequent surgeries (26.5%, 18/68 feet) in this current study included pain (n = 14), broken staples, and nonunion (n = 3). CONCLUSIONS: The fusion rate in this study, 89.7%, was similar to values reported in the literature. The patient satisfaction score of 81.9 at latest follow-up is consistent with patient satisfaction for other methods of fusion. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Subtalar Arthrodesis with Use of Adipose-Derived Cellular Bone Matrix Compared with Autologous Bone Graft: A Multicenter, Randomized Controlled Trial.

UPDATE: This article was updated on November 7, 2019, because of a previous error. On page 1909, in the section entitled "Discussion," the sentence that had read "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs" now reads "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do not account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs."An erratum has been published: J Bone Joint Surg Am. 2019 XXX. BACKGROUND: Subtalar arthrodesis effectively treats subtalar joint arthritis when other interventions have failed. Nonunion is a known complication of subtalar arthrodesis, with reported rates ranging from 5% to 45%. Historically, open arthrodesis has been performed with use of autologous bone graft; however, there are inherent disadvantages to autologous bone graft, including donor-site morbidity. Mesenchymal stem cells, when placed on a cellular scaffold, have shown promise as an alternative to autologous bone graft. The purpose of this multicenter, randomized controlled trial was to assess the safety and efficacy of an adipose-derived cellular bone matrix (ACBM) composite made with live cells compared with autograft in subtalar arthrodesis. METHODS: A total of 140 patients were enrolled in a prospective, randomized (1:1) controlled trial performed at 6 clinical sites in the U.S. End points, including radiographic, clinical, and functional outcomes, were assessed over 2 years of follow-up. RESULTS: A total of 109 patients underwent arthrodesis with ACBM (52 patients) and autograft (57 patients). At 6 months, fusion was achieved in 16 patients (30.8%) in the ACBM group and 31 patients (54.4%) in the autograft group as measured on computed tomography (p = 0.024), and in 41 patients (78.8%) in the ACBM group and 50 patients (87.7%) in the autograft group as assessed on clinical and radiographic evaluation (p = 0.213). Quality-of-life outcome measures demonstrated significant functional improvement from baseline for both groups. Fewer cases of serious adverse events occurred in the autograft group (10.5%) compared with the ACBM group (23.1%) (p = 0.078). CONCLUSIONS: In patients who require subtalar arthrodesis, the use of ACBM demonstrated lower rates of radiographic fusion compared with treatment with autograft. The nonunion rate in the autologous group, as measured on computed tomography, was high. Good clinical outcomes were achieved in spite of the high non-union rates. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Effectiveness and Safety of Ankle Arthrodesis Versus Arthroplasty: A Prospective Multicenter Study.

BACKGROUND: Newer designs and techniques of total ankle arthroplasty (TAA) have challenged the assumption of ankle arthrodesis (AA) as the primary treatment for end-stage ankle arthritis. The objective of this study was to compare physical and mental function, ankle-specific function, pain intensity, and rates of revision surgery and minor complications between these 2 procedures and to explore heterogeneous treatment effects due to age, body mass index (BMI), patient sex, comorbidities, and employment on patients treated by 1 of these 2 methods. METHODS: This was a multisite prospective cohort study comparing outcomes of surgical treatment of ankle arthritis. Subjects who presented after nonoperative management had failed received either TAA or AA using standard-of-treatment care and rehabilitation. Outcomes included the Foot and Ankle Ability Measure (FAAM), Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) scores, pain, ankle-related adverse events, and treatment success. RESULTS: Five hundred and seventeen participants underwent surgery and completed a baseline assessment. At 24 months, the mean improvement in FAAM activities of daily living (ADL) and SF-36 PCS scores was significantly greater in the TAA group than in the AA group, with a difference between groups of 9 points (95% confidence interval [CI] = 3, 15) and 4 points (95% CI = 1, 7), respectively. The crude incidence risks of revision surgery and complications were greater in the AA group; however, these differences were no longer significant after adjusting for age, sex, BMI, and Functional Comorbidity Index (FCI). The treatment success rate was greater after TAA than after AA for those with an FCI of 4 (80% versus 62%) and not fully employed (81% versus 58%) but similar for those with an FCI score of 2 (81% versus 77%) and full-time employment (79% versus 78%). CONCLUSIONS: At 2-year follow-up, both AA and TAA were effective. Improvement in several patient-reported outcomes was greater after TAA than after AA, without a significant difference in the rates of revision surgery and complications. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.