N/A
N=120
Jewel ACL Post Market Clinical Follow Up Study
Anterior Cruciate Ligament Injuries
Bottom Line
View on ClinicalTrials.gov: NCT04580290 ↗Enrolled (actual)
120
Serious AEs
5.0%
Results posted
Nov 2021
Primary outcome: Primary: Occurrence of Re-ruptures — 5; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JewelACL (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xiros Ltd
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Re-ruptures |
5; 1 | — |
Summary
The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.
Eligibility Criteria
Inclusion Criteria
- Age more than 18 years
- Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases)
Exclusion Criteria
- Age less than 18 years
- Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU)
- Revision cases
Data sourced from ClinicalTrials.gov (NCT04580290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.