Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome

NCT07204587 | Not Yet Recruiting DMC

• 1 other identifier: ChangGungMH MeniscusTransplant
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

meniscal allograft; autologous tendon graft; Post-meniscectomy syndrome; Meniscus deficiency

Outcome Measures

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.

  Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)

Secondary Outcomes (7)

• MRI-Based Graft Evaluation

  12 and 24 months postoperatively

• IKDC (International Knee Documentation Committee) Subjective Knee Evaluation

  Baseline, 6, 12, and 24 months after surgery

• Tegner Activity Scale

  Baseline, 6, 12, and 24 months after surgery

• Reoperation Rate

  Up to 24 months postoperatively

• Complications

  Within 24 months after surgery

Study Arms (4)

A1 Autologous Semitendinosus Tendon Graft (Randomized)

EXPERIMENTAL

Patients randomized to this arm will undergo meniscal reconstruction using autologous semitendinosus tendon grafts (diameter ≥ 6 mm). Standard two-tunnel fixation technique will be applied, with Fibertape internal brace augmentation. ACL reconstruction may be performed simultaneously if indicated.

Procedure: Autologous Semitendinosus Tendon Graft

A2 Meniscal Allograft Transplantation (Randomized)

EXPERIMENTAL

Patients randomized to this arm will receive size-matched fresh-frozen meniscal allografts. Fixation will be performed using the standard two-tunnel technique.

Procedure: Meniscal Allograft Transplantation (MAT)

Meniscal Allograft Transplantation (Patient Preference)

EXPERIMENTAL

Patients who decline randomization but choose allograft transplantation will undergo the same surgical procedure as Arm A2, with fresh-frozen meniscal allografts.

Procedure: Meniscal Allograft Transplantation (MAT)

Autologous Semitendinosus Tendon Graft (Patient Preference)

EXPERIMENTAL

Patients who decline randomization but choose autologous tendon grafting will undergo the same procedure as Arm A1, using semitendinosus tendon grafts with Fibertape internal brace augmentation.

Procedure: Autologous Semitendinosus Tendon Graft

Interventions

Autologous Semitendinosus Tendon Graft PROCEDURE

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.

A1 Autologous Semitendinosus Tendon Graft (Randomized); Autologous Semitendinosus Tendon Graft (Patient Preference)

Meniscal Allograft Transplantation (MAT) PROCEDURE

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.

A2 Meniscal Allograft Transplantation (Randomized); Meniscal Allograft Transplantation (Patient Preference)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 45 years
• History of partial meniscectomy \> 6 months prior to enrollment
• Symptomatic post-meniscectomy syndrome (knee pain, swelling, or functional decline)
• MRI showing cartilage status ≤ Outerbridge grade 2
• Knee joint stability (or stabilized during the index surgery)
• Body mass index (BMI) \< 30
• Willingness to provide written informed consent

You may not qualify if:

• Tibial slope \> 16°
• Radiographic or arthroscopic evidence of advanced cartilage degeneration (Outerbridge \> 2 or ICRS ≥ 3)
• Presence of inflammatory arthritis or systemic inflammatory joint disease
• History of cartilage repair surgery
• Malalignment \> 5° not corrected
• Untreated ligamentous instability
• Any other condition judged by the investigator to compromise study participation or outcomes

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Chang Gung memorial hospital, Taoyuan, taoyuan 333

Taoyuan, Taoyuan, 33305, Taiwan

Location

Related Publications (2)

• Seitz AM, Leiprecht J, Schwer J, Ignatius A, Reichel H, Kappe T. Autologous semitendinosus meniscus graft significantly improves knee joint kinematics and the tibiofemoral contact after complete lateral meniscectomy. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2956-2965. doi: 10.1007/s00167-022-07300-z. Epub 2023 Jan 5.

  PMID: 36604322 BACKGROUND

• Ronnblad E, Rotzius P, Eriksson K. Autologous semitendinosus tendon graft could function as a meniscal transplant. Knee Surg Sports Traumatol Arthrosc. 2022 May;30(5):1520-1526. doi: 10.1007/s00167-021-06606-8. Epub 2021 Jun 8.

  PMID: 34100999 BACKGROUND

Central Study Contacts

Cheng-Pang Yang

CONTACT

+886919087214; ronnie80097@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative MRI and patient-reported outcome measures (PROMs) will be evaluated by independent assessors blinded to treatment allocation. Participants, surgeons, and investigators will be aware of the intervention due to the surgical nature of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a stratified, partially randomized parallel assignment model. Eligible patients are allocated into four groups: randomized autologous semitendinosus tendon graft, randomized meniscal allograft transplantation, patient-preference autologous tendon graft, and patient-preference meniscal allograft transplantation. Even in the randomized groups, participants retain the option to switch to their preferred treatment after allocation, ensuring both methodological rigor and ethical feasibility. This design allows assessment of comparative outcomes under randomized conditions as well as in real-world preference-based clinical practice.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)