Radiographic and Magnetic Resonance Imaging of the Symptomatic Synthetic Cartilage Implant

An, Tonya; Cassinelli, Spenser J.; Charlton, Timothy P.; Pfeffer, Glenn B.; Thordarson, David B.

doi:10.1177/1071100719877147

Cited by 23 publications

(36 citation statements)

References 11 publications

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“…Cassinelli et al 4 presented the first study evaluating the PVA hydrogel implant outside of industry-sponsored studies. 1 They evaluated a cohort of 60 patients (64 implants), with 40 postoperative PROMIS Pain Interference scores, 42 postoperative PROMIS Physical Function scores, and 64 patient satisfaction responses. These authors report only descriptive statistics, with no baseline PROMIS scores to compare postoperative scores.…”

Section: Discussionmentioning

confidence: 99%

“…With an average clinical follow-up of 12.5 months, Cassinelli et al 4 reported therapeutic injections for 33 out of 64 joints (52%), reoperation for 13 out of 64 joints (20%), and conversion to arthrodesis for 5 out of 64 joints (8%). A recent study by An et al 1 evaluated 18 symptomatic implants from this cohort using MRI. We observed similar patterns of edema in the first metatarsal for patients with persistent postoperative pain who underwent MRI, which included 22 out of 103 patients (21.4%).…”

Section: Discussionmentioning

confidence: 99%

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Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus

et al. 2020

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus

et al. 2020

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“…Recent studies have presented less promising results with regard to the PVA implant at short-term follow-up. 1,5…”

Section: Discussionmentioning

confidence: 99%

“…While initial prospective randomized clinical trials demonstrated promising early results for patients treated with the PVA implant, other authors have reported less positive results. 1,4,5,12 Cassinelli et al 5 reported neutral patient satisfaction, mild pain and physical dysfunction postoperatively, and a relatively high conversion rate to arthrodesis (8%) at the early (1- to 2-year) follow-up. Additionally, in their cohort, 33 out of 64 implants (52%) were treated with corticosteroid injection for persistent pain, and 9 of 64 (14%) required additional dynamic splinting for functional range of motion limitations.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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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.

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“…Furthermore, a follow-up imaging study of our symptomatic implants has shown the implants to have radiolucencies around the implant on MR imaging and progressive loss of apparent joint space on plain radiographs. 1…”

mentioning

confidence: 99%

Response to “Letter Regarding: Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States”

Thordarson¹,

Cassinelli²,

Charlton³

et al. 2019

Foot Ankle Int.

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Radiographic and Magnetic Resonance Imaging of the Symptomatic Synthetic Cartilage Implant

Cited by 23 publications

References 11 publications

Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus

Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus

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

Response to “Letter Regarding: Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States”

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