Anterior Cruciate Ligament Injuries
Conditions
Brief 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.
Interventions
DEVICEJewelACL
The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction
Sponsors
Xiros Ltd
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Re-ruptures | Five Year | Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jewel ACL Only Subjects who received only the JewelACL | 88 |
| JewelACL + Autograft (Hybrid) Subjects who received the JewelACL + Autograft (hybrid) | 32 |
| Total | 120 |
Baseline characteristics
| Characteristic | Jewel ACL Only | JewelACL + Autograft (Hybrid) | Total |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 10.1 | 32.2 years STANDARD_DEVIATION 11.4 | 32.3 years STANDARD_DEVIATION 10.4 |
| Cause of ACL failure Not available | 10 Participants | 4 Participants | 14 Participants |
| Cause of ACL failure Other Accident | 3 Participants | 4 Participants | 7 Participants |
| Cause of ACL failure Sports Injury | 72 Participants | 23 Participants | 95 Participants |
| Cause of ACL failure Traffic Accident | 3 Participants | 1 Participants | 4 Participants |
| Femoral Fixation Endobutton TightRope Arthrex | 0 Participants | 1 Participants | 1 Participants |
| Femoral Fixation Linvatec XO | 0 Participants | 1 Participants | 1 Participants |
| Femoral Fixation Medgal Screw | 86 Participants | 29 Participants | 115 Participants |
| Femoral Fixation S+N EndoButton | 2 Participants | 1 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 71 Participants | 27 Participants | 98 Participants |
| Sports participation-yes | 66 Participants | 24 Participants | 90 Participants |
| Tibial Fixation Medgal screw | 88 Participants | 32 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 32 |
| other Total, other adverse events | 1 / 88 | 0 / 32 |
| serious Total, serious adverse events | 5 / 88 | 1 / 32 |
Outcome results
Primary
Occurrence of Re-ruptures
Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction
Time frame: Five Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JewelACL Only | Occurrence of Re-ruptures | 5 Participants |
| JewelACL + Autograft (Hybrid) | Occurrence of Re-ruptures | 1 Participants |