Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome

Summary

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.

Conditions

• Meniscal Injuries
• Meniscal Tear
• Meniscus Lesion

Interventions

PROCEDURE

Autologous Semitendinosus Tendon Graft

Meniscal 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.

PROCEDURE

Meniscal Allograft Transplantation (MAT)

Meniscal 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.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2028-09-30

Completion

2029-09-30

Countries

• Taiwan

Study Locations