Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States

2019 ◽  
Vol 40 (10) ◽  
pp. 1140-1148 ◽  
Author(s):  
Spenser J. Cassinelli ◽  
Stephanie Chen ◽  
Timothy P. Charlton ◽  
David B. Thordarson

Background: The aim of this study was to determine the early outcomes and complications following the implantation of a hydrogel synthetic cartilage implant (SCI, Cartiva) for the treatment of hallux rigidus by a single surgeon. Methods: A retrospective chart review was performed of consecutive patients who underwent treatment for hallux rigidus with an SCI between August 2016 and April 2018 by a single surgeon. Demographic information, radiographic assessment, and concomitant operative procedures performed were evaluated for all patients. Postoperatively, PROMIS physical function (PF) and pain interference (PI) scores, patient satisfaction, reoperation, conversion to arthrodesis, and need for further clinical treatment were collected. Sixty-four SCIs were implanted in 60 patients. Follow-up averaged 18.5 months (range 12-30 months). Results: 14% (9/64) of patients were very satisfied, 28% (18/64) satisfied, 20% (13/64) neutral, 11% (7/64) unsatisfied, and 27% (17/64) very unsatisfied with their outcome. In addition, 45% of patients underwent additional procedures at the time of SCI, and 23% had a history of surgery on the hallux before implantation. PROMIS PF scores averaged 42 and PROMIS PI scores averaged 60. Overall, 63% completed PROMIS PI, 66% completed PROMIS PF, and 100% completed a satisfaction survey. In addition, 30% (19/64) underwent magnetic resonance imaging (MRI) postoperatively due to pain. There was a 20% reoperation rate, which included an 8% rate of conversion to arthrodesis. Conclusion: Synthetic cartilage implantation yielded neutral patient satisfaction, mild pain, and physical dysfunction at early follow-up. We believe patient selection and counseling regarding early postoperative limitations are important before proceeding with SCI. Level of Evidence: Level IV, case series.

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0013
Author(s):  
Spenser J. Cassinelli ◽  
Stephanie Chen ◽  
Timothy P. Charlton ◽  
David B. Thordarson

Category: Midfoot/Forefoot Introduction/Purpose: The aim of this study was to determine the outcomes and early complications following the implantation of a novel hydrogel synthetic cartilage implant (SCI) for the treatment of hallux rigidus by a single surgeon. This implant was FDA approved for implantation for the treatment of hallux rigidus in the United States in July 2016. Methods: A retrospective chart review of consecutive patients who underwent treatment for hallux rigidus with an SCI between August 2016 and June 2018 by a single surgeon was performed. Demographic information, radiographic assessment, and concomitant surgical procedures performed were evaluated for all patients. Post operatively, PROMIS physical function and pain scores, patient satisfaction, reoperation, conversion to arthrodesis, and need for further clinical treatment were collected. Seventy SCI were implanted in 65 patients. Follow up averaged 16.3 months (Range 6-27 months). Results: 16% (11/67) of patients were very satisfied, 31% (21/67) were satisfied, 22% (15/67) were neutral, 6% (4/67) were dissatisfied, and 24% (16/67) were very dissatisfied with their outcome. PROMIS physical function scores averaged 43, indicating mild dysfunction compared to population norms. PROMIS pain interference scores averaged 59, indicating mild pain compared to population norms. 50% (35/70) required a corticosteroid injection post-operatively. 24% (17/70) required advanced imaging with MRI post-operatively. There was a 13% reoperation rate for all-cause reoperation, and a 2.9% rate of conversion to arthrodesis. Subgroup analysis showed that patients undergoing Moberg osteotomy at time of SCI performed better than patients undergoing SCI alone. Conclusion: Synthetic cartilage implantation yielded modest patient satisfaction, mild dysfunction in physical measures, and a large proportion requiring further treatment and workup post operatively. We believe patient selection and counseling on the potential for continued pain and dysfunction in the early postoperative period following this procedure are important before proceeding with synthetic cartilage implantation for hallux rigidus.


2021 ◽  
pp. 193864002110019
Author(s):  
Wonyong Lee ◽  
Carol Wang ◽  
Dan Prat ◽  
Keith L. Wapner ◽  
Wen Chao ◽  
...  

Background There remains no clear consensus on patient satisfaction and functional outcomes following synthetic cartilage implant (SCI) implantation for hallux rigidus. The purpose of this study was to review our experience at a single academic institution using an SCI for treatment of hallux rigidus. Methods A retrospective review was performed of patients who underwent the SCI procedure for treatment of hallux rigidus between January 2017 and May 2019. Functional outcomes were evaluated using Patient-Reported Outcome Measures Informational System (PROMIS)-10 scores as well as a survey investigating patient satisfaction, self-reported clinical improvement, and changes in sporting ability. Patients were divided into satisfied versus unsatisfied subgroups, and between-group differences in preoperative variables and complications were reviewed. A total of 90 patients (96 implants) were included in this study. The mean follow-up time was 26.4 months. Results In all, 81.2% of patients reported that their foot was “much improved” (55.2%) or “improved” (26.0%) since undergoing the SCI procedure, whereas a slightly lower percentage, 74.0%, stated that they were “extremely satisfied” (41.7%) or “satisfied” (32.3%) at final follow-up. Patients were able to tolerate higher impact sporting activities after the procedure, and 75.0% of patients stated they would have the same surgery again. PROMIS-10 T-scores averaged 54.2 points for physical health and 57.4 points for mental health. Only 2.1% of patients required conversion to arthrodesis. Significant differences between the satisfied versus unsatisfied subgroups were found in preoperative corticosteroid injection use (21.1% vs 41.1%, respectively; P = .029) and preoperative VAS pain score (8.2 vs 7.1, respectively; P = .036). Conclusion The SCI procedure can be a viable option for treating hallux rigidus with high satisfaction overall, increased sport activity levels, and a very low revision rate. However, maximizing patient satisfaction may require more careful consideration of preoperative prognosticators and extensive patient counseling to ensure realistic expectations for recovery time and individual outcome. Level of Evidence: Level IV: Retrospective case series


2020 ◽  
Vol 5 (3) ◽  
pp. 247301142093069
Author(s):  
William M. Engasser ◽  
J. Chris Coetzee ◽  
Patrick B. Ebeling ◽  
Bryan D. Den Hartog ◽  
Jeffrey D. Seybold ◽  
...  

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.


Joints ◽  
2017 ◽  
Vol 05 (01) ◽  
pp. 021-026 ◽  
Author(s):  
Cosimo Tudisco ◽  
Salvatore Bisicchia ◽  
Sandro Tormenta ◽  
Amedeo Taglieri ◽  
Ezio Fanucci

Purpose The purpose of this study was to evaluate the effect of correction of abnormal radiographic parameters on postoperative pain in a group of patients treated arthroscopically for femoracetabular impingement (FAI). Methods A retrospective study was performed on 23 patients affected by mixed-type FAI and treated arthroscopically. There were 11 males and 12 females with a mean age of 46.5 (range: 28–67) years. Center-edge (CE) and α angles were measured on preoperative and postoperative radiographic and magnetic resonance imaging (MRI) studies and were correlated with persistent pain at follow-up. Results The mean preoperative CE and α angles were 38.6 ± 5.2 and 67.3 ± 7.2 degrees, respectively. At follow-up, in the 17 pain-free patients, the mean pre- and postoperative CE angle were 38.1 ± 5.6 and 32.6 ± 4.8 degrees, respectively, whereas the mean pre- and postoperative α angles at MRI were 66.3 ± 7.9 and 47.9 ± 8.9 degrees, respectively. In six patients with persistent hip pain, the mean pre- and postoperative CE angles were 39.8 ± 3.6 and 35.8 ± 3.1 degrees, respectively, whereas the mean pre- and postoperative α angles were 70.0 ± 3.9 and 58.8 ± 2.6 degrees, respectively. Mean values of all the analyzed radiological parameters, except CE angle in patients with pain, improved significantly after surgery. On comparing patient groups, significantly lower postoperative α angles and lower CE angle were observed in patients without pain. Conclusion In case of persistent pain after arthroscopic treatment of FAI, a new set of imaging studies must be performed because pain may be related to an insufficient correction of preoperative radiographic abnormalities. Level of Evidence Level IV, retrospective case series.


2018 ◽  
Vol 40 (3) ◽  
pp. 268-275 ◽  
Author(s):  
Evan M. Loewy ◽  
Thomas H. Sanders ◽  
Arthur K. Walling

Background: Limited intermediate and no real long-term follow-up data have been published for total ankle arthroplasty (TAA) in the United States. This is a report of clinical follow-up data of a prospective, consecutive cohort of patients who underwent TAA by a single surgeon from 1999 to 2013 with the Scandinavian Total Ankle Replacement (STAR) prosthesis. Methods: Patients undergoing TAA at a single US institution were enrolled into a prospective study. These patients were followed at regular intervals with history, physical examination, and radiographs; American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale scores were obtained and recorded. Primary outcomes included implant survivability and functional outcomes scores. Secondary outcomes included perioperative complications such as periprosthetic or polyethylene fracture. Between 1999 and 2013, a total of 138 STAR TAAs were performed in 131 patients; 81 patients were female. The mean age at surgery was 61.5 ± 12.3 years (range, 30-88 years). The mean duration of follow-up for living patients who retained both initial components at final follow-up was 8.8±4.3 years (range 2-16.9 years). Results: The mean change in AOFAS Ankle-Hindfoot scores from preoperative to final follow-up was 36.0 ± 16.8 ( P < .0001). There were 21 (15.2%) implant failures that occurred at a mean 4.9 ± 4.5 years postoperation. Ten polyethylene components in 9 TAAs (6.5%) required replacement for fracture at an average 8.9 ± 3.3 years postoperatively. Fourteen patients died with their initial implants in place. Conclusion: This cohort of patients with true intermediate follow-up after TAA with the STAR prosthesis had acceptable implant survival, maintenance of improved patient-reported outcome scores, and low major complication rates. Level of Evidence: Level IV, case series.


2020 ◽  
Vol 5 (3) ◽  
pp. 247301142094490
Author(s):  
Carissa C. Dock ◽  
Katie L. Freeman ◽  
J. Chris Coetzee ◽  
Rebecca Stone McGaver ◽  
M. Russell Giveans

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.


2019 ◽  
Vol 4 (3) ◽  
pp. 247301141986402
Author(s):  
David P. Falk ◽  
Sreenivasulu Metikala ◽  
Viviana Serra Lopez ◽  
Matthew Stein ◽  
Karim Mahmoud ◽  
...  

In the United States, approximately 2000 stingray injuries occur annually. The majority of reports on stingray injuries to the foot and ankle reflect acute injuries. Delayed presentation after stingray injury to the foot and ankle has not been reported. We present a case of a 29-year-old female who sustained a stingray injury to the left plantar medial hindfoot 14 months prior to presenting to our clinic with new-onset posteromedial ankle redness and swelling along the tarsal tunnel. Magnetic resonance imaging (MRI) revealed multiple linear foreign bodies at the quadratus plantae and tarsal tunnel. The patient underwent operative exploration with removal of multiple retained stingray spines. At her most recent follow-up at 3 months, she was able to resume her usual activities. Level of Evidence: Level V, case report.


2017 ◽  
Vol 45 (4) ◽  
pp. 864-874 ◽  
Author(s):  
Rachel M. Frank ◽  
Simon Lee ◽  
David Levy ◽  
Sarah Poland ◽  
Maggie Smith ◽  
...  

Background: Osteochondral allograft transplantation (OAT) is being performed with increasing frequency, and the need for reoperations is not uncommon. Purpose: To quantify survival for OAT and report findings at reoperations. Study Design: Case series; Level of evidence, 4. Methods: A review of prospectively collected data of 224 consecutive patients who underwent OAT by a single surgeon with a minimum follow-up of 2 years was conducted. The reoperation rate, timing of reoperation, procedure performed, and findings at surgery were reviewed. Failure was defined by revision OAT, conversion to knee arthroplasty, or gross appearance of graft failure at second-look arthroscopic surgery. Results: A total of 180 patients (mean [±SD] age, 32.7 ± 10.4 years; 52% male) who underwent OAT with a mean follow-up of 5.0 ± 2.7 years met the inclusion criteria (80% follow-up). Of these, 172 patients (96%) underwent a mean of 2.5 ± 1.7 prior surgical procedures on the ipsilateral knee before OAT. Forty-eight percent of OAT procedures were isolated, while 52% were performed with concomitant procedures including meniscus allograft transplantation (MAT) in 65 (36%). Sixty-six patients (37%) underwent a reoperation at a mean of 2.5 ± 2.5 years, with 32% (21/66) undergoing additional reoperations (range, 1-3). Arthroscopic debridement was performed in 91% of patients with initial reoperations, with 83% showing evidence of an intact graft; of these, 9 ultimately progressed to failure at a mean of 4.1 ± 1.9 years. A total of 24 patients (13%) were considered failures at a mean of 3.6 ± 2.6 years after the index OAT procedure because of revision OAT (n = 7), conversion to arthroplasty (n= 12), or appearance of a poorly incorporated allograft at arthroscopic surgery (n = 5). The number of previous surgical procedures was independently predictive of reoperations and failure; body mass index was independently predictive of failure. Excluding the failed patients, statistically and clinically significant improvements were found in the Lysholm score, International Knee Documentation Committee score, Knee injury and Osteoarthritis Outcome Score, and Short Form–12 physical component summary at final follow-up ( P < .001 for all), with inferior outcomes (albeit overall improved) in patients who underwent a reoperation. Conclusion: In this series, there was a 37% reoperation rate and an 87% allograft survival rate at a mean of 5 years after OAT. The number of previous ipsilateral knee surgical procedures was predictive of reoperations and failure. Of the patients who underwent arthroscopic debridement with an intact graft at the time of arthroscopic surgery, 82% experienced significantly improved outcomes, while 18% ultimately progressed to failure. This information can be used to counsel patients on the implications of a reoperation after OAT.


2017 ◽  
Vol 39 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Ettore Vulcano ◽  
Andy L. Chang ◽  
David Solomon ◽  
Mark Myerson

Background: Capsular interposition arthroplasty is a joint- and motion-sparing procedure that has been shown as an effective alternative to fusion. This study aimed to evaluate patient function and satisfaction after long-term follow-up. Methods: Sixty-four patients were treated with capsular interposition arthroplasty for hallux rigidus by the senior author performed between February 1998 and July 2011. Twenty-two patients could not be reached for follow-up and were thus excluded from the analysis. Therefore, 42 remaining patients were evaluated using the visual analog scale (VAS), Foot Function Index (FFI), Short Form 12 (SF-12), and patient satisfaction scores. The mean follow-up was 11.3 (range, 4-16) years. Results: The mean VAS for pain was 7.9 preoperatively and 1.8 postoperatively ( P = .003). The mean preoperative SF-12 physical score was 42.0 vs 64.2 postoperatively ( P = .02). The mean preoperative SF-12 mental score was 50.7, while the postoperative SF-12 mental score was 54.6 ( P = .01). The total FFI score also significantly improved, with a preoperative value of 98.3 and a postoperative mean score of 49.6 ( P = .001). The mean patient satisfaction score was 7.4 of 10. Overall, 39 of 42 patients (92.9%) stated they would have the surgery again. Four of the 42 patients (9.5%) required conversion to hallux metatarsophalangeal fusion at a mean of 6.1 years after the index procedure secondary to pain, but no other complications were reported. Conclusion: Capsular interposition arthroplasty was a safe and effective treatment for severe hallux rigidus. These longer term results demonstrate a high level of patient satisfaction. Level of Evidence: Level IV, retrospective case series.


2019 ◽  
Vol 40 (10) ◽  
pp. 1114-1121 ◽  
Author(s):  
Eliezer Sidon ◽  
Ryan Rogero ◽  
Timothy Bell ◽  
Elizabeth McDonald ◽  
Rachel J. Shakked ◽  
...  

Background:Hallux rigidus is the most common arthritic condition in the foot. First metatarsophalangeal joint cheilectomy produces satisfactory results in retrospective studies with reported good to excellent results in up to 97% and pain relief and function in 92%. The results of cheilectomy for higher grades of hallux rigidus are less favorable. The purpose of this study was to evaluate the long-term functional results and survivorship of cheilectomy for treatment of hallux rigidus.Methods:This was a retrospective, questionnaire-based study investigating the long-term results of cheilectomy for treatment of hallux rigidus. The preoperative arthritic grade was graded retrospectively according to the Hattrup and Johnson (H&J) grading system. A questionnaire was administered via email or telephone that included questions regarding pain recurrence following surgery, current functional status, and satisfaction with the operation. Kaplan-Meier survival analysis was performed to estimate survival time between arthritic grades. We reviewed 165 patients (169 feet) with an average follow-up of 6.6 (5.0-10.9) years.Results:The overall survival rate (painless at the time of last follow-up) was 70.4% (119 feet), with no significant difference between the 3 H&J arthritic grades. Most of the recurrences (28 feet, 75%) were at the first 2 years following the surgery. Nine feet (5.3%) had a second procedure at a mean postoperative time of 3.6 (range, 1.6-7.4) years. Of the 169 feet, 117 (69.3%) reported being satisfied or very satisfied and 127 (75.1%) indicated they would repeat the operation under the same circumstances.Conclusion:Our study supports the use of cheilectomy for treatment of hallux rigidus (grade 1-3 Coughlin and Shurnas) as a reliable procedure with favorable results. At long-term follow-up, patients who underwent cheilectomy had a low revision rate and a moderately low rate of pain recurrence.Level of Evidence:Level IV, retrospective case-series.


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