The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique (BPTB，Meniscus)

Beijing Tsinghua Chang Gung Hospital

Status: Not yet enrolling

Conditions: Meniscal Tears; ACL - Anterior Cruciate Ligament Rupture

Treatments: Procedure: Quasi-anatomical meniscus allograft transplantation; Procedure: bone-patellar tendon-bone or meniscus allograft transplantation techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT07088094

12110000318301495P (Other Identifier)

25076-3-01

Details and patient eligibility

About

This clinical study investigates the outcomes of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques in patients requiring joint reconstruction. The study aims to assess the safety, efficacy, and functional improvements following these transplant procedures, utilizing donor tissues to restore joint function and alleviate pain in individuals with severe knee damage. Participants will undergo the transplantation procedure and be monitored for post-operative recovery, complications, and long-term outcomes, including joint stability and mobility. The study seeks to provide valuable insights into the effectiveness of these advanced surgical techniques for knee joint repair.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-50 years
• Clinical diagnosis of symptomatic meniscal deficiency and anterior cruciate ligament injury (complete rupture or severe damage)
• Failure of conservative treatment (e.g., physical therapy, analgesia) for ≥6 months
• Stable knee joint (no ligamentous instability confirmed via clinical exam and MRI)
• Willingness to comply with postoperative rehabilitation and follow-up evaluations

Exclusion criteria

• Severe tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≥3)
• History of prior knee infection or septic arthritis
• Inflammatory arthritis (e.g., rheumatoid arthritis, gout)
• BMI ≥35 kg/m²
• Pregnancy or planning pregnancy during the study period
• Concurrent full-thickness chondral defects (Outerbridge grade III-IV) in the affected compartment
• Inability to undergo MRI (e.g., claustrophobia, metallic implants)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Bone-patellar tendon-bone allograft transplantation

Experimental group

Description:

Bone-patellar tendon-bone allograft transplantation

Treatment:

Procedure: bone-patellar tendon-bone or meniscus allograft transplantation techniques

Control group

No Intervention group

Description:

non-surgical or conservative treatment group

Quasi-anatomical meniscus allograft transplantation

Experimental group

Description:

Quasi-anatomical meniscus allograft transplantation

Treatment:

Procedure: Quasi-anatomical meniscus allograft transplantation