Comparison Between Polyvinyl Alcohol Implant and Cheilectomy With Moberg Osteotomy for Hallux Rigidus

2020 ◽  
Vol 41 (9) ◽  
pp. 1031-1040 ◽  
Author(s):  
Bopha Chrea ◽  
Stephanie K. Eble ◽  
Jonathan Day ◽  
Scott J. Ellis ◽  
Mark C. Drakos ◽  
...  

Background: In 2016, the US Food and Drug Administration (FDA) approved the use of a polyvinyl alcohol (PVA) hydrogel implant for the surgical management of hallux rigidus. Though recent studies have evaluated the safety and efficacy of the implant, no study has compared outcomes following PVA implantation with those following traditional joint-preserving procedures for hallux rigidus, such as cheilectomy with Moberg osteotomy. The purpose of this study was to compare clinical and patient-reported outcomes for patients undergoing cheilectomy and Moberg osteotomy, with or without PVA implant, at a single multisurgeon academic center. Our hypothesis was that the addition of the PVA implant would result in superior clinical and patient-reported outcomes. Methods: In total, 166 patients were identified who underwent cheilectomy and Moberg osteotomy with (PVACM; n = 72) or without (CM; n = 94) a PVA implant between January 2016 and December 2018 by 1 of 8 foot and ankle fellowship-trained orthopedic surgeons at our institution. Of these patients, 60 PVACM and 73 CM patients had both baseline and minimum 1-year postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores. The average time to survey follow-up was 14.5 months for PVACM patients and 15.6 months for CM patients. Retrospective chart review was performed to assess the incidence of postoperative complications and reoperations, with an average clinical follow-up of 27.7 (range, 16.0-46.4) months for PVACM patients and 36.6 (range, 18.6-47.8) months for CM patients. Results: Both PVACM and CM cohorts demonstrated significant improvement in the PROMIS Physical Function, Pain Interference, Pain Intensity, and Global Physical Health domains when comparing preoperative and postoperative scores within each group ( P < .01). When comparing scores between the PVACM and CM cohorts, preoperative scores were similar, while CM patients demonstrated significantly higher postoperative Physical Function (51.8 ± 8.7 vs 48.8 ± 8.0; P = .04) and significantly lower Pain Intensity (39.9 ± 8.3 vs 43.4 ± 8.7; P = .02) scores. The pre- to postoperative change in Physical Function was also significantly greater for CM patients (7.1 ± 8.5 vs 3.6 ± 6.2; P = .011). In the PVACM group, there were 3 revisions (5%), 1 reimplantation, 1 conversion to arthrodesis, and 1 revision to correct hyperdorsiflexion. In the CM group, there was 1 revision (1.4%), a conversion to arthrodesis ( P = .21). Other postoperative complications included persistent pain (7 out of 60 PVACM patients [11.7%] and 8 out of 73 CM patients [11.0%]; P = .90) and infection in 3 PVACM patients (5%) and no CM patients ( P = .05). Conclusion: Though our results generally support the safety and utility of the PVA implant as previously established by the clinical trial, at 1 to 2 years of follow-up, CM without a PVA implant may provide equivalent or better relief compared with a PVACM procedure, while avoiding potential risks associated with the implant. Level of Evidence: Level III, retrospective comparative study.

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0017
Author(s):  
Bopha Chrea ◽  
Jonathan Day ◽  
Stephanie K. Eble ◽  
Megan Reilly ◽  
Jonathan T. Deland ◽  
...  

Category: Midfoot/Forefoot; Other Introduction/Purpose: In 2016, the US Food and Drug Administration (FDA) approved the use of a polvinvyl alcohol (PVA) hydrogel implant (Cartiva, Elmsford, NY) for surgical treatment of hallux rigidus, or degenerative arthritis of the first metatarsophalangeal (1st MTP) joint. While studies have demonstrated the safety and usability of PVA implant, clinical outcomes following hemiarthroplasty with the PVA have not yet been compared to that of traditional joint-preserving procedures such as cheilectomy with Moberg osteotomy in the treatment of hallux rigidus. The purpose of this study is to compare patient-reported outcomes and postoperative complications between PVA hemiarthroplasty and cheilectomy with Moberg osteotomy, with the hypothesis that the addition of PVA would result in superior clinical outcomes. Methods: Patients were retrospectively identified who underwent hallux rigidus correction by one of seven Foot and Ankle fellowship-trained orthopaedic surgeons between March 2016 and November 2018. Out of 162 patients, a total of 133 patients constituted our study cohort after excluding patients with insufficient follow-up. Of the 133, 60 patients (mean age 57.2 years) were treated with combination PVA, cheilectomy, and Moberg osteotomy (PCM) and 73 patients (mean age 54.1) were treated with cheilectomy and Moberg (CM) alone. Both preoperative as well as minimum 1-year postoperative patient-reported outcome scores (PROMIS) were compared between the two cohorts. Chart review was performed to compare rates of revision and complications. Results: Average time to follow-up was 14.5 months for PCM and 15.6 for CM groups. Both PCM and CM cohorts demonstrated significant improvement in PROMIS scores, with the CM group demonstrating significantly greater increase in Physical Function (7.14 +- 8.48 vs 3.58 +- 6.24, p=0.01). While preoperative scores were comparable, postoperatively the CM group had a significantly higher average Physical Function (51.8 +- 8.7 vs 48.8 +- 8.0, p=0.04) and lower Pain Intensity (39.9 +- 8.3 vs 43.4 +- 8.7, p=0.02). There were 2 cases of revision with re-implantation and 1 case of conversion to arthrodesis in the PCM group. There was 1 case of conversion to PVA in the CM group. Three patients who underwent PCM had a documented postoperative infection requiring antibiotics. Conclusion: Our data suggests that the addition of polyvinyl alcohol implant in the treatment of hallux rigidus results in significant improvement in patient-reported outcomes. However, patient-reported physical function may not be up to par at minimum 1-year follow-up compared to cheilectomy and Moberg osteotomy alone. In addition, while incidence was low in our cohort, revision of the implant as well as conversion to arthrodesis remain possible complications of PVA. Therefore, we believe that proper patient selection is recommended when considering surgical treatment options for hallux rigidus. [Table: see text]


2018 ◽  
Vol 40 (1) ◽  
pp. 65-73 ◽  
Author(s):  
Man Hung ◽  
Judith F. Baumhauer ◽  
Frank W. Licari ◽  
Maren W. Voss ◽  
Jerry Bounsanga ◽  
...  

Background: Establishing score points that reflect meaningful change from the patient perspective is important for interpreting patient-reported outcomes. This study estimated the minimum clinically important difference (MCID) values of 2 Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and the Foot and Ankle Ability Measure (FAAM) Sports subscale within a foot and ankle orthopedic population. Methods: Patients seen for foot and ankle conditions at an orthopedic clinic were administered the PROMIS Physical Function (PF) v1.2, the PROMIS Pain Interference (PI) v1.1, and the FAAM Sports at baseline and all follow-up visits. MCID estimation was conducted using anchor-based and distribution-based methods. Results: A total of 3069 patients, mean age of 51 years (range = 18-94), were included. The MCIDs for the PROMIS PF ranged from approximately 3 to 30 points (median = 11.3) depending on the methods being used. The MCIDs ranged from 3 to 25 points (median = 8.9) for the PROMIS PI, and from 9 to 77 points (median = 32.5) for the FAAM Sports. Conclusions: This study established a range of MCIDs in the PROMIS PF, PROMIS PI, and FAAM Sports indicating meaningful change in patient condition. MCID values were consistent across follow-up periods, but were different across methods. Values below the 25th percentile of MCIDs may be useful for low-risk clinical decisions. Midrange values (eg, near the median) should be used for high stakes decisions in clinical practice (ie, surgery referrals). The MCID values within the interquartile range should be utilized for most decision making. Level of Evidence: Level I, diagnostic study, testing of previously developed diagnostic measure on consecutive patients with reference standard applied.


2021 ◽  
pp. 107110072110078
Author(s):  
Peter Y. Joo ◽  
Judith F. Baumhauer ◽  
Olivia Waldman ◽  
Samantha Hoffman ◽  
Jeffrey Houck ◽  
...  

Background: Hallux rigidus is a common and painful degenerative condition of the great toe limiting a patient’s physical function and quality of life. The purpose of this study was to investigate pre- and postoperative physical function (PF) and pain interference (PI) levels of patients undergoing synthetic cartilage implant hemiarthroplasty (SCI) vs arthrodesis (AD) for treatment of hallux rigidus using the Patient-Reported Outcomes Measurement Information System (PROMIS). Methods: PROMIS PF and PI t scores were analyzed for patients who underwent either SCI or AD. Postoperative final PROMIS t scores were obtained via phone survey. Linear mixed model analysis was used to assess differences in PF and PI at each follow-up point. Final follow-up scores were analyzed using independent sample t tests. Results: Total 181 (59 SCI, 122 AD) operatively managed patients were included for analysis of PROMIS scores. Final phone survey was performed at a minimum of 14 (mean 33, range, 14-59) months postoperatively, with 101 patients (40 SCI, 61 AD) successfully contacted. The mean final follow-up was significantly different for SCI and AD: 27 vs 38 months, respectively ( P < .01). The mean age of the SCI cohort was lower than the AD cohort (57.5 vs 61.5 years old, P = .01). Average PF t scores were higher in the SCI cohort at baseline (47.1 and 43.9, respectively, P = .01) and at final follow-up (51.4 vs 45.9, respectively, P < .01). A main effect of superior improvement in PF was noted in the SCI group (+4.3) vs the AD group (+2) across time intervals ( P < .01). PI t scores were similar between the 2 procedures across time points. Conclusion: The SCI cohort reported slightly superior PF t scores preoperatively and at most follow-up time points compared with the arthrodesis group. No differences were found for PI or complication rates between the 2 treatment groups during this study time frame. Level of Evidence: Level III.


2020 ◽  
Vol 41 (5) ◽  
pp. 549-555
Author(s):  
Todd Kim ◽  
Andrew Haskell

Background: While smaller talar dome osteochondral lesions (OCLs) are successfully treated with bone marrow stimulation techniques, the optimal treatment for large or cystic OCLs remains controversial. This study tested the hypothesis that transferring structural autograft bone from the distal tibia to the talus for large or cystic OCLs improves pain and function. Methods: Thirty-two patients with large or cystic OCLs underwent structural bone grafting from the ipsilateral distal tibia to the talar dome. Patients were assessed with subjective patient-centered tools and objective clinical outcomes. Average age was 48.6 ± 14.9 years, and average follow-up was 19.5 ± 13.3 months. Average lesion area was 86.2 ± 23.5 mm2, and average depth was 8.4 ± 3.0mm. Results: At final follow-up, improvement compared to preoperative scores was seen in American Orthopaedic Foot & Ankle Society (65.4 ± 21.2 to 86.9 ± 15.0, P < .05), Foot Function Index (48.9 ± 20.8 to 21.1 ± 18.9, P < .05), visual analog scale for pain (4.7 ± 3.0 to 1.4 ± 1.5, P < .05), and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (40.4 ± 5.4 to 45.5 ± 7.4, P < .05) scores. There was no improvement in PROMIS pain interference (54.7 ± 18.1 to 52.4 ± 7.3, P > .05). Satisfaction with surgery was 8.4 ± 1.3/10, and 96% of patients would have the procedure again. Ninety-four percent of patients returned to work and/or play. One patient had a deep vein thrombosis 6 weeks postoperatively, and 1 patient underwent ankle fusion at 18 months postoperatively. Conclusion: This study demonstrates that structural bone graft harvested from the distal tibia transferred to the talus was a safe and effective treatment for large and cystic OCLs. Outcomes compare favorably to other described techniques for treatment of these injuries. Level of Evidence: Level IV, case series.


2021 ◽  
Vol 49 (3) ◽  
pp. 764-772
Author(s):  
Matthew S. Tenan ◽  
Joseph W. Galvin ◽  
Timothy C. Mauntel ◽  
John M. Tokish ◽  
James R. Bailey ◽  
...  

Background: The preferred patient-reported outcome measure for the assessment of shoulder conditions continues to evolve. Previous studies correlating the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) to the American Shoulder and Elbow Surgeons (ASES) score have focused on a singular domain (pain or physical function) but have not evaluated the combined domains of pain and physical function that compose the ASES score. Additionally, previous studies have not provided a multivariable prediction tool to convert PROMIS scores to more familiar legacy scores. Purpose: To establish a valid predictive model of ASES scores using a nonlinear combination of PROMIS domains for physical function and pain. Study Design: Cohort study (Diagnosis); Level of evidence, 3. Methods: The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient-reported outcomes and intraoperative variables. Patients in MOTION research who underwent shoulder surgery and completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at varying time points were included in the present analysis. Nonlinear multivariable predictive models were created to establish an ASES index score and then validated using “leave 1 out” techniques and minimal clinically important difference /substantial clinical benefit (MCID/SCB) analysis. Results: A total of 909 patients completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at presurgery, 6 weeks, 6 months, and 1 year after surgery, providing 1502 complete observations. The PROMIS CAT predictive model was strongly validated to predict the ASES (Pearson coefficient = 0.76-0.78; R2 = 0.57-0.62; root mean square error = 13.3-14.1). The MCID/SCB for the ASES was 21.7, and the best ASES index MCID/SCB was 19.4, suggesting that the derived ASES index is effective and can reliably re-create ASES scores. Conclusion: The PROMIS CAT predictive models are able to approximate the ASES score within 13 to 14 points, which is 7 points more accurate than the ASES MCID/SCB derived from the sample. Our ASES index algorithm, which is freely available online ( https://osf.io/ctmnd/ ), has a lower MCID/SCB than the ASES itself. This algorithm can be used to decrease patient survey burden by 11 questions and provide a reliable ASES analog to clinicians.


2018 ◽  
Vol 39 (5) ◽  
pp. 517-521 ◽  
Author(s):  
Andrew Haskell ◽  
Todd Kim

Background: The authors describe a method of collecting patient-reported outcomes (PROs) using computerized adaptive tests (CATs) in a high-volume orthopedic surgery practice with limited resources and no research coordinator. Methods: Patient-Reported Outcomes Measurement Information System CATs were collected prospectively for all clinic patients using a tablet and recorded in the electronic medical record. Scores were compared with validated national norms using single-variable t tests. Linear regression was used to assess age effects. Preoperative and postoperative pain scales were compared using paired t tests. Results: In total, 4,524 CATs were administered during 10,719 visits (42%), reaching 70% as more tablets were introduced. Completing the CATs required 157 seconds. Older patients took more time than younger ones ( P < .05). Compared with normalized t scores of 50 ± 10 for the US population, pain intensity was 48.0 (95% confidence interval [CI], 47.8-48.2), pain interference 58.9 (95% CI, 58.6-59.1), physical function 40.1 (95% CI, 39.9-40.3), global physical health 43.4 (95% CI, 41.9-44.9), and global mental health 41.1 (95% CI, 40.89-41.4) ( P < .05 for all). Age had a small effect on all domains ( P < .05). Approximately 20 patients would be required to demonstrate a 15% change for a 2-tailed, paired study with α = 0.05 and 80% power. After surgery, pain intensity improved from 51.9 ± 8.2 to 44.1 ± 8.5, pain interference improved from 62.5 ± 6.9 to 55.7 ± 8.4, and physical function improved from 37.3 ± 8.9 to 41.5 ± 7.9 ( P < .05 for all). Conclusions: Using tablets to administer CATs and entering the data in the electronic medical record for later retrieval was an effective technique to collect PROs. An adequate number of tablets are needed for acceptable completion rates. Modest sample size requirements for comparative studies highlight the potential of these tools and techniques. Level of Evidence: Level II, Prospective Comparative Study


2021 ◽  
pp. 107110072110469
Author(s):  
Matthew S. Conti ◽  
Tamanna J. Patel ◽  
Jiaqi Zhu ◽  
Andrew J. Elliott ◽  
Stephen F. Conti ◽  
...  

Background: The purpose of this study was to determine if a postoperative decrease in first metatarsal pronation on 3-dimensional imaging was associated with changes in patient-reported outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, pain interference, and pain intensity domains or recurrence rates in patients with hallux valgus (HV) who undergo a first tarsometatarsal fusion (modified Lapidus procedure). Methods: Thirty-nine consecutive HV patients who met the inclusion criteria and underwent a modified Lapidus procedure had preoperative and ≥2-year postoperative PROMIS scores and had first metatarsal pronation measured on preoperative and at least 5-month postoperative weightbearing CT scans were included. Multivariable regression analyses were used to investigate differences in the change in PROMIS domains preoperatively and 2 years postoperatively between patients with “no change/increased first metatarsal pronation” and “decreased first metatarsal pronation.” A log-binomial regression analysis was performed to identify if a decrease in first metatarsal pronation was associated with recurrence of the HV deformity. Results: The decreased first metatarsal pronation group had a significantly greater improvement in the PROMIS physical function scale by 7.2 points ( P = .007) compared with the no change/increased first metatarsal pronation group. Recurrence rates were significantly lower in the decreased first metatarsal pronation group when compared to the no change/increased first metatarsal pronation group (risk ratio 0.25, P = .025). Conclusion: Detailed review of this limited cohort of patients who underwent a modified Lapidus procedure suggests that the rotational component of the HV deformity may play an important role in outcomes and recurrence rates following the modified Lapidus procedure. Level of Evidence: Level III, retrospective cohort study.


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.


2020 ◽  
Vol 41 (9) ◽  
pp. 1056-1064
Author(s):  
Stephanie K. Eble ◽  
Oliver B. Hansen ◽  
Bopha Chrea ◽  
Taylor N. Cabe ◽  
Jonathan Garfinkel ◽  
...  

Background: Hallux rigidus is a common arthritic condition that has been addressed surgically with a range of techniques, from an isolated cheilectomy to first metatarsophalangeal (MTP) joint fusion. Recently, hemiarthroplasty with polyvinyl alcohol (PVA) hydrogel implant has been used as an alternative treatment to relieve pain while preserving motion of the first MTP joint. We retrospectively reviewed patient-reported outcome scores and clinical outcomes for patients treated for hallux rigidus with PVA hydrogel implant at an academic, multisurgeon center. Methods: A total of 103 patients who underwent first MTP hemiarthroplasty with PVA hydrogel implant between January 2017 and October 2018 were retrospectively reviewed (average, 26.2 months). Eight surgeons were represented. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) scores for the Physical Function, Pain Interference, Pain Intensity, Global Physical Health, Global Mental Health, and Depression domains were collected prospectively and compared with PROMIS scores collected at a minimum of 1 year postoperatively (average, 13.9 months). Seventy-three patients had both preoperative and postoperative scores. Ten of these patients had undergone a prior procedure of the first MTP, and 52 underwent concurrent Moberg osteotomy at the time of PVA hydrogel implantation. Results: For patients with baseline and postoperative PROMIS scores, significant pre- to postoperative improvement was detected for the Physical Function, Pain Interference, Pain Intensity, and Global Physical Health domains ( P < .05). Patients who had undergone a prior procedure of the first MTP had significantly higher postoperative Pain Intensity scores compared with those who did not undergo a prior procedure. Patients undergoing concurrent Moberg osteotomy had significantly lower postoperative Pain Interference and Pain Intensity scores compared with those who did not undergo a Moberg. Two patients underwent revision procedures in the first 2 years postoperatively, one with revision hemiarthroplasty and one with conversion to arthrodesis. Conclusion: On average across our entire cohort, physical function and pain scores improved significantly pre- to postoperatively; however, postoperative pain scores were significantly higher for patients who had undergone a prior procedure of the first MTP and significantly lower for patients who underwent concurrent Moberg osteotomy. The implant displayed excellent survivorship in the first 2 years postoperatively, with only 2 revision procedures. Level of Evidence: Level III, comparative series.


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