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Completed
NCT07723625
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
Conditions: ACL Injury, ACL Tear
Sex: All
Ages: 20 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: PT. Prodia Stem Cell Indonesia
Location: Prof. dr. I.G.N.G. Ngoerah General Hospital Denpasar Bali
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07723625). StuddyBuddy aggregates publicly available trial information.