Acute Ruptures of the Anterior Cruciate Ligament
Conditions
Keywords
ACL, knee injury, anterior cruciate ligament
Brief summary
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.
Interventions
PROCEDUREHamstring Autograft
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.
DEVICEL-C Ligament
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.
Sponsors
Soft Tissue Regeneration, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury
Exclusion criteria
* Prior ACL reconstruction or other surgical procedure on the affected (target) knee * Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury * Professional athletes currently engaged in active sport * Prior distal femoral and/or proximal tibial fracture(s) of the target leg * Previous or current ACL injury on contra-lateral leg * Multi-ligament reconstruction * Malalignment or varus thrust * Patient \> 193 cm tall (6' 4) * The patient does not follow pre-operative rehabilitation that may have been prescribed post-injury (prior to Index Procedure) * Confirmed connective tissue disorder * Signs of moderate to severe degenerative joint disease * Severe pain, swelling, or redness within 24 hours prior to surgery * Complete or partial Posterior Cruciate Ligament (PCL) tear * If concomitant meniscal injury is present, any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears * Any type of lateral and/or medial meniscal tear which is not repairable (\<2mm from rim) * Additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the Inclusion criteria * The patient is unwilling to not participate in sporting activities for at least 9 months post-procedure * The patient is mentally compromised * The patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care * The patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously * Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or breast-feeding * The patient is obese with a BMI \> 35 * The patient has a known allergy to PLLA * The patient has a medical condition or comorbidity that would interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Failure | 12 Months | Revision surgery rate at one year |
| Physical Knee Function measured by the IKDC | 12 Months | Physical Knee Function at 12 Months post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Day 1 | Pain levels day 1 post-procedure |
| Adverse event rates | 12 months | Rate of AEs throughout the first year of follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale | over 24 months | Physical activity level scores at all follow-up timepoints through Month 24 |
| Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS | over 24 months | KOOS scores at all follow-up timepoints through Month 24 |
| Physical Knee Function as measured by the Lysholm scale | over 24 months | Physical Knee Function scores at all follow-up timepoints through Month 24 |
Countries
Netherlands
Outcome results
None listed