WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY
Research type
Research Study
Full title
WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY
IRAS ID
270988
Contact name
Andrew Bing
Contact email
Sponsor organisation
Wright Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Research Summary
Wright Medical is conducting the Foot and Ankle Observational Study to meet the new clinical data requirements for the EU MDR. The purpose of this post-market clinical observational study is to demonstrate the safety/performance of the Wright Medical product after implantation over standard follow-up period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays). Additionally, PROMs and safety may be followed yearly to sufficiently assess the safety of the product over the clinical lifetime as needed based on the current risk analysis for the product. The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).
The study will demonstrate the safety and performance of the Wright Medical product by:
• Comparing the improvements in patient-reported pain and social interaction for QOL from pre-op through post-operatively, assessed by the EQ-5D-5L.
• Comparing the improvement in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM
• Identifying/reporting the safety of the implant in terms of complications and adverse events.
• Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
• Conducting patient surveys to assess current implant status (to include complications)Subjects to be included in the study must meet all of the following criteria:
• Willing/able to consent to participate (written, informed consent);
• Willing/ able to attend/complete the requested follow-up visits;
• Considered for treatment with one or more approved or cleared Wright Medical products included in this studySubjects will be excluded from the study if they meet any of the following criteria:
• Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
• Unable to consent to participate (written, informed consent);
• Unable to attend/complete the requested follow-up visitsSummary of Results
Since the study ended early, study devices didn’t reach the enrollment goal of 40 subjects. For the same sample size parameters in the protocol, n=10 will yield a power of 0.5. Thus, for the purpose of reporting statistically valid outcomes, descriptive analysis summary statistics are presented for Wright devices implanted in at least 10 patients enrolled in the study. Below are the results for all implants that had 10 or more patients enrolled.
DARCO™ Headed Screws
The results of the evaluation demonstrated that subjects treated with DARCO™ Headed Screws met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, both the visual analogue scale and the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures.
Per surgeon assessment at the final follow-up visit, 100% (n=38) of treated subjects’ DARCO Headed Screws performed as intended. The LE DARCO™ Headed/Headless Screw System Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved in 95% of the population. In this study, 100% (n=35) of the subjects implanted with DARCO™ Headed Screws that were evaluated at the final visit for bony union/bone consolidation achieved successful bony union. 12 safety events occurred in 9 subjects (23.1%), with only 3 events in 3 subjects (7.7%) considered serious, and no reported deaths nor device deficiencies. Six (6) events in five (12.8%) implanted subjects were considered procedure related. Only 1 event in 1 subject (2.6%) was considered device related.DARTFIRE™
The results of the evaluation demonstrated that subjects treated with DARTFIRE™ met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, both the visual analogue scale and the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures. Per surgeon assessment at the final follow-up visit, 100% (n=34) of treated subjects’ DARTFIRE™ devices performed as intended. The LE DARTFIRE™ SMALL SCREWS Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved in 88.4% of the population. In this study, 93.75% (n=30) of the subjects implanted with DARTFIRE™ that were evaluated for bony union/bone consolidation at the final visit achieved successful bony union. Lastly, four safety events occurred in four subjects (11.4%), with no events considered serious, and no reported deaths nor device deficiencies
ORTHOLOC™ Hallux
The results of the evaluation demonstrated that subjects treated with ORTHOLOC™ Hallux met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, both the visual analogue scale and the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures. Per surgeon assessment at the final follow-up visit, 100% (n=26) of treated subjects’ ORTHOLOC™ Hallux devices performed as intended. The LE ORTHOLOC™ 3DI HALLUX Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved range of 95%-100% of the population. The subjects in this study fell within this range, as 100% (n=25) of the subjects implanted with ORTHOLOC™ Hallux that were evaluated for bony union/bone consolidation at the final visit achieved successful bony union. Lastly, three safety events occurred in as many subjects (10.7%), with no events considered serious, and no reported deaths nor device deficiencies. Two events (7.1%) were considered procedure-related, with one event (3.6%) considered device-related.
CHARLOTTE™ Snap-Off Screws
Of the 18 subjects treated with the CHARLOTTE™ Snap-Off Screws able to be evaluated for safety outcomes, 2 events occurred in 2 subjects (11.8%). No events were considered procedure-related nor device-related. One event (5.6%) was considered Serious. This was classified as Pain along the 1st metatarsal at the site of screw presence, but TMT joint fusion was confirmed by radiography. The SAE was resolved at the time of study closure. No subject deaths nor device deficiencies were reported in this study.
DARCO™ MFS
The results of the evaluation demonstrated that subjects treated with DARCO™ MFS met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures, apart from the ADL subscale. Per surgeon assessment at the final follow-up visit, 94.1% (n=16) of treated subjects’ DARCO™ MFS performed as intended. The LE DARCO™ LOCKING BONE PLATE SYSTEM Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved in 99.6% of the population. The subjects in this study fell below this rate, as 90.9% (n=10) of the subjects implanted with DARCO™ MFS that were evaluated for bony union/bone consolidation at the final visit achieved successful bony union. Lastly, ten safety events occurred in seven subjects (41.2%), with only one event (5.9%) considered serious, and no reported deaths nor device deficiencies.
ORTHOLOC™ Midfoot Flatfoot
The results of the evaluation demonstrated that subjects treated with ORTHOLOC™ Midfoot Flatfoot met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, both the visual analogue scale and the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures. Per surgeon assessment at the final follow-up visit, 93.3% (n=14) of treated subjects’ ORTHOLOC™ Midfoot Flatfoot devices performed as intended. The LE ORTHOLOC™ 3DI MIDFOOT/FLATFOOT YSTEM Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved in 93.4% of the population for midfoot fusions and 100% of the population for midfoot osteotomies. The subjects in this study fell below this range, as 85.71% (n=12) of the subjects implanted with ORTHOLOC™ Midfoot Flatfoot that were evaluated for bony union/bone consolidation at the final visit achieved successful bony union. The clinical evaluation report also established 5 degree and 4.8 degree change in Meary’s Angle in for midfoot osteotomies and midfoot fusions, respectively. For ORTHOLOC™ Midfoot Flatfoot treated subjects (n=4) assessed for Meary’s Angle, the mean change from baseline was 6.25 ± 27.6 at the final follow-up visit. Lastly, 7 safety events occurred in 7 subjects (43.8%), with five events in four subjects (25%) considered serious, and no reported deaths nor device deficiencies. One of the SAEs was considered procedure and device related, and one SAE was considered procedure related. The other two weren’t considered procedure or device related.
DARCO™ Headless Screws
The results of the evaluation demonstrated that subjects treated with DARCO™ Headless Screws met the primary and secondary efficacy objectives, as well as demonstrated safety. In evaluating the primary efficacy objective at the final visit with the EQ-5D, both the visual analogue scale and the index score for the subjects showed an increase in their self-perceived health quality of life. And in evaluating secondary efficacy objectives at the final visit with the FAAM, the subjects showed an increase in their self-assessed physical functionality across all measures, apart from the Sports subscale and Overall Function. Per surgeon assessment at the final follow-up visit, 100% (n=14) of treated subjects’ DARCO™ Headless Screws performed as intended. The LE DARCO™ Headed/Headless Screw System Clinical Evaluation Report established the criteria to assess clinical outcomes as successful bone consolidation/fusion achieved in 95% of the population. In this study, 100% (n=2) of the subjects implanted with DARCO™ Headless Screws that were evaluated for bony union/bone consolidation at the final visit achieved successful bony union. Lastly, eight safety events occurred in five subjects (35.7%), with none considered serious, and no reported deaths nor device deficiencies. Two events in two subjects (14.3 %) were considered procedure-related. Seven events in five subjects (35.7%) were considered device-related.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0380
Date of REC Opinion
31 Dec 2019
REC opinion
Favourable Opinion