Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruc… (NCT07723625) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Tendon Grafts With Adjunctive Secretome Injection Versus Without Secretome Injection
Indonesia24 participantsStarted 2025-11-14
Plain-language summary
Anterior cruciate ligament (ACL) reconstruction is commonly performed to restore knee stability after ACL injury; however, graft healing remains a critical determinant of successful outcomes. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of adjunctive MSC-derived secretome injection administered to the graft during arthroscopic single-bundle ACL reconstruction using a peroneus longus tendon autograft. Twenty-four participants were randomized to receive either secretome injection or placebo. Functional outcomes were assessed using the IKDC Subjective Knee Evaluation Form and the Tegner-Lysholm Knee Scoring Scale before surgery and at six months postoperatively. The study evaluated whether adjunctive secretome injection could improve functional recovery compared with placebo while monitoring treatment safety.
Who can participate
Age range
20 Years – 40 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:
* Complete anterior cruciate ligament (ACL) rupture confirmed by magnetic resonance imaging (MRI).
* Positive pivot-shift test.
* Positive Lachman test.
* Positive anterior drawer test.
* Scheduled to undergo arthroscopic ACL reconstruction using a peroneus longus tendon autograft.
* Surgery performed by the same surgical team.
* Age 18 to \<40 years.
Exclusion Criteria:
* Partial ACL tear.
* History of previous ACL reconstruction surgery.
* Multi-ligament knee injury involving more than two ligaments.
* Generalized ligamentous laxity confirmed using the Beighton Hypermobility Score.
* Unwilling or unable to comply with the scheduled follow-up through 6 months postoperatively.
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.
What they're measuring
1
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Timeframe: Baseline (preoperative) and 6 months after surgery
2
Tegner-Lysholm Knee Scoring Scale
Timeframe: Baseline (preoperative) and 6 months postoperatively.