Status:
TERMINATED
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
Lead Sponsor:
Soft Tissue Regeneration, Inc.
Conditions:
Acute Ruptures of the Anterior Cruciate Ligament
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02183727
Start Date
September 1 2015
End Date
July 1 2020
Last Update
November 22 2021
Active Locations (1)
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1
Isala Klinieken
Zwolle, Netherlands