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The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality).
There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-Lig | Experimental | Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure. |
|
| Allograft | Active Comparator | Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-Lig | Device | ACL replacement |
| |
| allograft |
| Measure | Description | Time Frame |
|---|---|---|
| KT-1000 | Contact Sponsor | baseline, 3,6, 12 & 24 monhts |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Sponsor | Belgium | |||||
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| Label | URL |
|---|---|
| Click here for more information about this study: Z-Lig compared to Allograft | View source |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Device |
ACL replacement |
|
| Contact Sponsor |
| Denmark |
| Bologna | Italy |
| Contact Sponsor | Netherlands |
| Contact Sponsor | South Africa |
| Contact Sponsor | Spain |