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 range
18 Years – 45 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.