ACL Injury, ACL Tear
Conditions
Brief 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.
Interventions
BIOLOGICALSecretome
A single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome
BIOLOGICALPlacebo
Normal Saline Placebo
Sponsors
PT. Prodia Stem Cell Indonesia
RS Prof. Dr. I.G.N.G Ngoerah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score | Baseline (preoperative) and 6 months after surgery | The IKDC Subjective Knee Evaluation Form assesses symptoms, knee function, and ability to perform sports activities. Scores range from 0 to 100, with higher scores indicating better knee function. |
| Tegner-Lysholm Knee Scoring Scale | Baseline (preoperative) and 6 months postoperatively. | The Tegner-Lysholm Knee Scoring Scale evaluates knee function, pain, instability, locking, swelling, stair climbing, squatting, limp, and need for support. Scores range from 0 to 100, with higher scores indicating better functional outcomes. |
Countries
Indonesia
Outcome results
None listed