Clinical trial NCT02183727: L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
Official title: L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Ruptures of the Anterior Cruciate Ligament
Keywords: ACL
knee injury
anterior cruciate ligament
Lead sponsor: Soft Tissue Regeneration, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Graft Failure
timeFrame: 12 Months
measure: Physical Knee Function measured by the IKDC
timeFrame: 12 Months
Secondary outcomes:
measure: Pain Score
timeFrame: Day 1
measure: Adverse event rates
timeFrame: 12 months
Other outcomes:
measure: Physical Knee Function as measured by the Lysholm scale
timeFrame: over 24 months
measure: Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale
timeFrame: over 24 months
measure: Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS
timeFrame: over 24 months
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Isala Klinieken, Zwolle, The Netherlands
name: Kees van Egmond, MD
role: PRINCIPAL_INVESTIGATOR
References: