Cartiva: A Retrospective Multicenter Report
Category: Midfoot/Forefoot; Other Introduction/Purpose: Arthritis of the 1st metatarsophalangeal (MTP) joint is a common condition. Traditionally, advanced disease has been treated with arthrodesis. In 2016, Cartiva, a cylindrical polyvinyl 1st MTP implant, was approved for use in this condition by...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2020-10-01
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| Series: | Foot & Ankle Orthopaedics |
| Online Access: | https://doi.org/10.1177/2473011420S00026 |
| _version_ | 1818456171049123840 |
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| author | Nicholas Casscells MD Daniel M. Dean MD Paul S. Cooper MD Stuart D. Miller MD Gregory P. Guyton MD |
| author_facet | Nicholas Casscells MD Daniel M. Dean MD Paul S. Cooper MD Stuart D. Miller MD Gregory P. Guyton MD |
| author_sort | Nicholas Casscells MD |
| collection | DOAJ |
| description | Category: Midfoot/Forefoot; Other Introduction/Purpose: Arthritis of the 1st metatarsophalangeal (MTP) joint is a common condition. Traditionally, advanced disease has been treated with arthrodesis. In 2016, Cartiva, a cylindrical polyvinyl 1st MTP implant, was approved for use in this condition by the FDA upon the basis of a company-sponsored, nonblinded, randomized controlled trial (MOTION) that reported noninferiority to arthrodesis at a -15% difference of proportions margin using a multipart ad hoc definition of surgical success. A subsequent independent level IV case series reported poor PROMIS score outcomes for the procedure but lacked any preoperative data. We report the short-term reoperation rate and pre- and postoperative VAS pain score outcomes for Cartiva in an independent multicenter series. Methods: A retrospective, multicenter review was performed of patients who had a Cartiva hemiarthroplasty placed from 2016- 18 and who had at least 6 months of follow-up. Demographic information, surgical data, and prospectively collected VAS pain scores on a 0-100 point scale on were reviewed. The primary endpoint was reoperation of the implant, defined as removal or revision during the follow-up period. Implant subsidence was measured by comparing early postoperative radiographs with final radiographs. Subgroup analysis was performed comparing Cartiva failures to the remainder of the group. Results: Fifty-three patients with 56 operated toes were included. Forty-seven (88.7%) females and 6 (11.3%) males had a mean age of 57.7 +- 7.14 years (range 43-73). At an average follow-up of 11.1 +- 4.24 months, there were 6 (10.7%) reoperations. Younger age was the only factor found to be associated with failure of the implant (p=.043). Radiographic subsidence >1 mm was identified in 26.6% of patients but did not correlate with failure. VAS pain scores improved from a preoperative average of 49.7 +/- 24.8 to a postoperative average of 33.1 +- 23.3 at final follow-up. Despite this improvement, 40.4% of patients failed to show a 30% improvement, the MCID, in their VAS pain score, and 42.6% of patients had residual pain scores above 30. Conclusion: Our cohort had a 10.7% reoperation rate for the Cartiva implant which is comparable to the results of the MOTION trial. Although aggregate results demonstrated a statistically significant improvement in VAS pain scores, many patients failed to have a satisfactory outcome as demonstrated by the large standard deviation and low achievement of the MCID. Compared to the 1-year results of the MOTION study, our final VAS pain scores were slightly worse, but the very high variance mirrored that reported in the company-sponsored trail (17.8 +- 23.0). This suggests that use of Cartiva does not reliably produce satisfactory pain outcomes. |
| first_indexed | 2024-12-14T22:22:25Z |
| format | Article |
| id | doaj.art-b5dc002289274b72a1604e8ef911c333 |
| institution | Directory Open Access Journal |
| issn | 2473-0114 |
| language | English |
| last_indexed | 2024-12-14T22:22:25Z |
| publishDate | 2020-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Foot & Ankle Orthopaedics |
| spelling | doaj.art-b5dc002289274b72a1604e8ef911c3332022-12-21T22:45:28ZengSAGE PublishingFoot & Ankle Orthopaedics2473-01142020-10-01510.1177/2473011420S00026Cartiva: A Retrospective Multicenter ReportNicholas Casscells MDDaniel M. Dean MDPaul S. Cooper MDStuart D. Miller MDGregory P. Guyton MDCategory: Midfoot/Forefoot; Other Introduction/Purpose: Arthritis of the 1st metatarsophalangeal (MTP) joint is a common condition. Traditionally, advanced disease has been treated with arthrodesis. In 2016, Cartiva, a cylindrical polyvinyl 1st MTP implant, was approved for use in this condition by the FDA upon the basis of a company-sponsored, nonblinded, randomized controlled trial (MOTION) that reported noninferiority to arthrodesis at a -15% difference of proportions margin using a multipart ad hoc definition of surgical success. A subsequent independent level IV case series reported poor PROMIS score outcomes for the procedure but lacked any preoperative data. We report the short-term reoperation rate and pre- and postoperative VAS pain score outcomes for Cartiva in an independent multicenter series. Methods: A retrospective, multicenter review was performed of patients who had a Cartiva hemiarthroplasty placed from 2016- 18 and who had at least 6 months of follow-up. Demographic information, surgical data, and prospectively collected VAS pain scores on a 0-100 point scale on were reviewed. The primary endpoint was reoperation of the implant, defined as removal or revision during the follow-up period. Implant subsidence was measured by comparing early postoperative radiographs with final radiographs. Subgroup analysis was performed comparing Cartiva failures to the remainder of the group. Results: Fifty-three patients with 56 operated toes were included. Forty-seven (88.7%) females and 6 (11.3%) males had a mean age of 57.7 +- 7.14 years (range 43-73). At an average follow-up of 11.1 +- 4.24 months, there were 6 (10.7%) reoperations. Younger age was the only factor found to be associated with failure of the implant (p=.043). Radiographic subsidence >1 mm was identified in 26.6% of patients but did not correlate with failure. VAS pain scores improved from a preoperative average of 49.7 +/- 24.8 to a postoperative average of 33.1 +- 23.3 at final follow-up. Despite this improvement, 40.4% of patients failed to show a 30% improvement, the MCID, in their VAS pain score, and 42.6% of patients had residual pain scores above 30. Conclusion: Our cohort had a 10.7% reoperation rate for the Cartiva implant which is comparable to the results of the MOTION trial. Although aggregate results demonstrated a statistically significant improvement in VAS pain scores, many patients failed to have a satisfactory outcome as demonstrated by the large standard deviation and low achievement of the MCID. Compared to the 1-year results of the MOTION study, our final VAS pain scores were slightly worse, but the very high variance mirrored that reported in the company-sponsored trail (17.8 +- 23.0). This suggests that use of Cartiva does not reliably produce satisfactory pain outcomes.https://doi.org/10.1177/2473011420S00026 |
| spellingShingle | Nicholas Casscells MD Daniel M. Dean MD Paul S. Cooper MD Stuart D. Miller MD Gregory P. Guyton MD Cartiva: A Retrospective Multicenter Report Foot & Ankle Orthopaedics |
| title | Cartiva: A Retrospective Multicenter Report |
| title_full | Cartiva: A Retrospective Multicenter Report |
| title_fullStr | Cartiva: A Retrospective Multicenter Report |
| title_full_unstemmed | Cartiva: A Retrospective Multicenter Report |
| title_short | Cartiva: A Retrospective Multicenter Report |
| title_sort | cartiva a retrospective multicenter report |
| url | https://doi.org/10.1177/2473011420S00026 |
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