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

Not Applicable

Not yet recruiting

• Conditions: Meniscal Tears; ACL - Anterior Cruciate Ligament Rupture

• Registration Number: NCT07088094
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-18
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-01
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Complications Unit of Measure	2 years	Unit of Measure: Percentage of patients with complications (e.g., infection, graft failure, arthrofibrosis); Description: This measure evaluates the incidence of postoperative complications in patients undergoing bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. The complications will be classified according to the Clavien-Dindo Classification for surgical complications, with clinical evaluations using physical examination and imaging to assess the occurrence of adverse events. The results will be reported as the percentage of patients experiencing any form of complication during the postoperative period.; Measurement Tool: Clavien-Dindo Classification for surgical complications, clinical evaluation through physical examination, and imaging studies.
Functional Improvement in Knee Joint Unit of Measure-Knee Society Score (KSS)	2 years	Unit of Measure: Improvement in functional scores (0-100 scale); Description: This measure evaluates the improvement in knee function following bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. Functional outcomes will be assessed using the Knee Society Score (KSS); What it measures: Knee Score (0-100): Knee-specific symptoms, alignment, stability. Function Score (0-100): Walking distance, stair-climbing, use of aids. Score Meaning: Higher = Better outcome. Note: Reported as two separate scores (not combined).; Measurement Tool: Knee Society Score (KSS) and Lysholm Knee Score. The scale use a 0-100 range, where higher scores always indicate better knee function/health.
Functional Improvement in Knee Joint Unit of Measure-Lysholm Knee Score	2 years	Unit of Measure: Improvement in functional scores (0-100 scale); Description: This measure evaluates the improvement in knee function following bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. Functional outcomes will be assessed using Lysholm Knee Score.; Full Name: Lysholm Knee Scoring Scale Range: 0-100 What it measures: Stability, pain, daily function. Score Meaning: Higher = Better outcome.; Measurement Tool: Lysholm Knee Score. The scale use a 0-100 range, where higher scores always indicate better knee function/health.