L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction (NCT02183727) | Clinical Trial Compass
TerminatedPhase 2/3
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
Stopped: Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.
Netherlands60 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ment…