Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome

NCT ID: NCT07204587

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-09-30

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.

Detailed Description

Post-meniscectomy syndrome represents a challenging condition in young adults, characterized by persistent pain, swelling, and functional impairment after partial or subtotal meniscectomy. The lack of sufficient meniscal tissue predisposes patients to abnormal tibiofemoral loading and early onset osteoarthritis. Current reconstructive options remain limited, and there is no consensus on the optimal surgical strategy.

Meniscal allograft transplantation (MAT) has been the most widely accepted method, offering immediate restoration of meniscal morphology and load-distributing capacity. However, MAT is constrained by donor availability, graft costs, and local regulations. In contrast, autologous tendon grafts-most commonly using semitendinosus-are readily available, carry no risk of rejection, and reduce cost barriers. Early biomechanical and translational studies suggest that autologous tendon grafts may adapt to meniscal-like properties, yet long-term clinical data remain scarce.

This trial employs a stratified, partially randomized design to balance methodological rigor with patient autonomy and ethical feasibility. Participants are assigned to autologous tendon graft or MAT either through randomization or patient preference, allowing assessment of outcomes under both controlled and real-world conditions. All procedures are standardized across participating centers, utilizing a two-tunnel fixation technique and augmented with an internal brace (Fibertape) to enhance graft stability.

Outcomes will be assessed over 24 months, including validated patient-reported measures (KOOS, IKDC, Tegner), MRI-based graft evaluation (volume, signal, extrusion, morphology), reoperation rates, complications, satisfaction, and return-to-sport. By integrating randomized comparison with pragmatic elements, this study aims to generate clinically applicable evidence on the relative benefits and limitations of autologous tendon graft versus MAT. The findings are expected to inform surgical decision-making, optimize patient outcomes, and guide future treatment recommendations for young patients suffering from post-meniscectomy syndrome.

Conditions

Meniscal Injuries; Meniscal Tear; Meniscus Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A1 Autologous Semitendinosus Tendon Graft (Randomized)

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.

Group Type: EXPERIMENTAL

Autologous Semitendinosus Tendon Graft

Intervention Type: 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.

A2 Meniscal Allograft Transplantation (Randomized)

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

Group Type: EXPERIMENTAL

Meniscal Allograft Transplantation (MAT)

Intervention Type: 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.

Meniscal Allograft Transplantation (Patient Preference)

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

Group Type: EXPERIMENTAL

Meniscal Allograft Transplantation (MAT)

Intervention Type: 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.

Autologous Semitendinosus Tendon Graft (Patient Preference)

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.

Group Type: EXPERIMENTAL

Autologous Semitendinosus Tendon Graft

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung memorial hospital, Taoyuan, taoyuan 333

Taoyuan, Taoyuan, Taiwan

Countries

Taiwan

Central Contacts

Cheng-Pang Yang

Role: CONTACT

ronnie80097@gmail.com

+886919087214

Facility Contacts

Cheng-Pang Yang

Role: primary

ronnie80097@gmail.com

+886 0919087214

References

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.

Reference Type: BACKGROUND

PMID: 36604322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34100999 (View on PubMed)

Other Identifiers

ChangGungMH MeniscusTransplant

Identifier Type: -

Identifier Source: org_study_id