Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChang Gung Memorial Hospital
About this trial
This multicenter, stratified, partially randomized clinical trial aims to compare autologous semitendinosus tendon graft and meniscal allograft transplantation (MAT) in young adults with post-meniscectomy syndrome. The meniscus plays a critical role in load distribution, shock absorption, and joint stability. After meniscectomy, insufficient meniscal tissue often leads to persistent pain, swelling, and functional decline, increasing the risk of early osteoarthritis.
Two reconstructive strategies are clinically available: MAT provides immediate biomechanical function but requires donor matching and carries higher costs, while autologous tendon graft offers stable supply and no immunologic risk but lacks long-term clinical validation.
In this study, 40 patients aged 18-45 years will be enrolled. Participants will be allocated into four groups (randomized MAT, randomized autograft, patient-preference MAT, patient-preference autograft). All procedures will use a two-tunnel fixation technique with additional internal brace support.
The primary endpoint is the improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) at 24 months postoperatively. Secondary endpoints include MRI-based assessment of graft morphology and extrusion, reoperation rate, complications, patient satisfaction, and return-to-sport time.
This trial will provide critical evidence regarding the comparative effectiveness and feasibility of tendon autograft versus meniscal allograft in real-world clinical settings, potentially informing surgical decision-making and future treatment guidelines for post-meniscectomy syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 45 years
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous Semitendinosus Tendon Graft
Procedure/SurgeryMeniscal reconstruction will be performed using autologous semitendinosus tendon harvested from the ipsilateral leg. The graft diameter must be at least 6 mm. A two-tunnel fixation technique will be employed, securing the graft to the tibial plateau at the anatomic meniscal root sites. The graft will be shaped and positioned to mimic the native meniscal contour. Fibertape internal brace augmentation will be added to enhance fixation strength and graft stability. If concomitant anterior cruciate ligament reconstruction is indicated, the graft choice and ACL technique will be determined by the surgeon, without restriction. Postoperative rehabilitation will follow a standardized protocol across all centers.
Meniscal Allograft Transplantation (MAT)
Procedure/SurgeryMeniscal allograft transplantation will use size-matched, fresh-frozen allograft menisci prepared according to institutional tissue bank standards. Grafts will be fixed using a two-tunnel bone plug technique, restoring the anatomic root insertions. The allograft will be centrally positioned within the tibiofemoral compartment, and centralization sutures may be added at the discretion of the operating surgeon. All procedures will be standardized across participating centers, and postoperative rehabilitation protocols will be identical to those used in the autologous graft arm.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: A1 Autologous Semitendinosus Tendon Graft (Randomized)Experimental treatment 1 intervention
Group B: A2 Meniscal Allograft Transplantation (Randomized)Experimental treatment 1 intervention
Group C: Meniscal Allograft Transplantation (Patient Preference)Experimental treatment 1 intervention
Group D: Autologous Semitendinosus Tendon Graft (Patient Preference)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Knee Injury and Osteoarthritis Outcome Score
The KOOS questionnaire evaluates knee-related symptoms, pain, activities of daily living, sports/recreation function, and knee-related quality of life. The primary endpoint is the change in KOOS total score from baseline to 24 months postoperatively.
Time frame
Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)Secondary outcomes
1
MRI-Based Graft Evaluation
MRI assessment of graft morphology including volume, signal distribution, shape, and extrusion, evaluated by blinded radiologists
Time frame
12 and 24 months postoperatively2
IKDC (International Knee Documentation Committee) Subjective Knee Evaluation
Patient-reported outcome questionnaire assessing symptoms, daily and sports activities, and knee function
Time frame
Baseline, 6, 12, and 24 months after surgery3
Tegner Activity Scale
Patient-reported physical activity level, ranging from daily living to competitive sports participation.
Time frame
Baseline, 6, 12, and 24 months after surgery4
Reoperation Rate
Incidence of revision surgery or additional procedures related to meniscal reconstruction
Time frame
Up to 24 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Chang Gung Memorial Hospital
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov
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