Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability
Category: Ankle; Sports Introduction/Purpose: Ankle sprains represent one of the most common injuries in the population (1). Most sprains resolve with conservative therapy, however, failure resulting in ligament laxity may require surgical intervention from pain and instability from injury to the an...
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SAGE Publishing
2024-12-01
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| Series: | Foot & Ankle Orthopaedics |
| Online Access: | https://doi.org/10.1177/2473011424S00417 |
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| author | Bryan G. Vopat MD Ryan Scott DPM |
| author_facet | Bryan G. Vopat MD Ryan Scott DPM |
| author_sort | Bryan G. Vopat MD |
| collection | DOAJ |
| description | Category: Ankle; Sports Introduction/Purpose: Ankle sprains represent one of the most common injuries in the population (1). Most sprains resolve with conservative therapy, however, failure resulting in ligament laxity may require surgical intervention from pain and instability from injury to the anterior talofibular ligament (ATFL) (2). Surgical repair of the ATFL has relatively high success rates, however post-procedure chronic instability and pain remain a clinical challenge, with re-operation rates reported up to 14% (3). Artelon ® FlexBand ® matrix (Artelon, Sandy Springs, GA) is a copolymer of polyurethane urea and polycaprolactone (PUUR), a synthetic matrix designed to reinforce soft tissue repair during tendon/ligament reconstructive procedures. The goal of this study is to present patient reported outcomes (PROs) after modified Broström repair with PUUR augmentation device compared to historically reported ATFL repairs. Methods: This multi-center, IRB approved study is collecting data on patients that have undergone ATFL repair (isolated and non-isolated) with PUUR augmentation. These results represent an interim data analysis of an ongoing clinical study. A total of 47 patients diagnosed with chronic lateral ankle instability that had failed conservative therapy, and required surgical intervention to repair the lateral ligament complex were enrolled across two different research centers. Patient demographics, patient reported outcomes (PROs), safety, and complications were collected. PROs included Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM), visual analog pain score (VAS), and Veterans Rand-12 (VR-12) at 2-, 6-, 12-weeks, 6-months and 1- and 2-year follow-up visits. Results: The average patient age was 40 years, and average BMI was 30.9. There is a statistical difference in VAS scores at all follow-up times after surgery (2 weeks to 2 years) compared to pre-surgery, with long term VAS scores at 1 and 2 years showing the greatest improvement (0.76 and 0.88, respectively, p< 001) compared to baseline. Similarly, FFI scores showed significant improvement at 12 weeks to 2 years. FAAM scores in PUUR augmented patients significantly improved at 6 months, 1 year and 2 year follow-up. Patient general health assessed by VR-12 showed significant improvement at longer term 1- and 2-year follow-up (Figure 1). There were no procedure or product related adverse events or complications necessitating a return to the OR for any patient. Conclusion: Our data shows a significant improvement in VAS as well as improvements in foot specific PROs, FFI and FAAM in patients who underwent the modified Brostrom procedure with augmentation. Future studies will address Flexband augmentation vs. modified Brostrom in parallel in a randomized, prospective study. |
| format | Article |
| id | doaj-art-8d7dc61beb884d2bbb5bf50aadb8b653 |
| institution | OA Journals |
| issn | 2473-0114 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Foot & Ankle Orthopaedics |
| spelling | doaj-art-8d7dc61beb884d2bbb5bf50aadb8b6532025-08-20T01:57:21ZengSAGE PublishingFoot & Ankle Orthopaedics2473-01142024-12-01910.1177/2473011424S00417Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle InstabilityBryan G. Vopat MDRyan Scott DPMCategory: Ankle; Sports Introduction/Purpose: Ankle sprains represent one of the most common injuries in the population (1). Most sprains resolve with conservative therapy, however, failure resulting in ligament laxity may require surgical intervention from pain and instability from injury to the anterior talofibular ligament (ATFL) (2). Surgical repair of the ATFL has relatively high success rates, however post-procedure chronic instability and pain remain a clinical challenge, with re-operation rates reported up to 14% (3). Artelon ® FlexBand ® matrix (Artelon, Sandy Springs, GA) is a copolymer of polyurethane urea and polycaprolactone (PUUR), a synthetic matrix designed to reinforce soft tissue repair during tendon/ligament reconstructive procedures. The goal of this study is to present patient reported outcomes (PROs) after modified Broström repair with PUUR augmentation device compared to historically reported ATFL repairs. Methods: This multi-center, IRB approved study is collecting data on patients that have undergone ATFL repair (isolated and non-isolated) with PUUR augmentation. These results represent an interim data analysis of an ongoing clinical study. A total of 47 patients diagnosed with chronic lateral ankle instability that had failed conservative therapy, and required surgical intervention to repair the lateral ligament complex were enrolled across two different research centers. Patient demographics, patient reported outcomes (PROs), safety, and complications were collected. PROs included Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM), visual analog pain score (VAS), and Veterans Rand-12 (VR-12) at 2-, 6-, 12-weeks, 6-months and 1- and 2-year follow-up visits. Results: The average patient age was 40 years, and average BMI was 30.9. There is a statistical difference in VAS scores at all follow-up times after surgery (2 weeks to 2 years) compared to pre-surgery, with long term VAS scores at 1 and 2 years showing the greatest improvement (0.76 and 0.88, respectively, p< 001) compared to baseline. Similarly, FFI scores showed significant improvement at 12 weeks to 2 years. FAAM scores in PUUR augmented patients significantly improved at 6 months, 1 year and 2 year follow-up. Patient general health assessed by VR-12 showed significant improvement at longer term 1- and 2-year follow-up (Figure 1). There were no procedure or product related adverse events or complications necessitating a return to the OR for any patient. Conclusion: Our data shows a significant improvement in VAS as well as improvements in foot specific PROs, FFI and FAAM in patients who underwent the modified Brostrom procedure with augmentation. Future studies will address Flexband augmentation vs. modified Brostrom in parallel in a randomized, prospective study.https://doi.org/10.1177/2473011424S00417 |
| spellingShingle | Bryan G. Vopat MD Ryan Scott DPM Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability Foot & Ankle Orthopaedics |
| title | Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability |
| title_full | Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability |
| title_fullStr | Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability |
| title_full_unstemmed | Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability |
| title_short | Patient Reported Outcomes from an Open Label, Multi-Center, Retrospective Study of a Biodegradable Graft for Soft Tissue Reconstruction in Patients Suffering from Chronic Lateral Ankle Instability |
| title_sort | patient reported outcomes from an open label multi center retrospective study of a biodegradable graft for soft tissue reconstruction in patients suffering from chronic lateral ankle instability |
| url | https://doi.org/10.1177/2473011424S00417 |
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