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Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.
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The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-C Ligament | Experimental | Soft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time. |
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| Hamstring Autograft | Active Comparator | Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-C Ligament | Device | The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Failure | Revision surgery rate at one year | 12 Months |
| Physical Knee Function measured by the IKDC | Physical Knee Function at 12 Months post procedure | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain levels day 1 post-procedure | Day 1 |
| Adverse event rates | Rate of AEs throughout the first year of follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Knee Function as measured by the Lysholm scale | Physical Knee Function scores at all follow-up timepoints through Month 24 | over 24 months |
| Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kees van Egmond, MD | Isala Klinieken, Zwolle, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Netherlands |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Hamstring Autograft | Procedure | The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated. |
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Physical activity level scores at all follow-up timepoints through Month 24
| over 24 months |
| Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS | KOOS scores at all follow-up timepoints through Month 24 | over 24 months |