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

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.

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Key information

Conditions

Meniscal Tears ACL - Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bone-patellar tendon-bone or meniscus allograft transplantation techniques

Procedure

This clinical study follows an interventional design, focusing on the evaluation of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques。

Quasi-anatomical meniscus allograft transplantation

Procedure

Quasi-anatomical meniscus allograft transplantation

Primary outcomes

Incidence of Postoperative Complications Unit of Measure

Time frame: 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)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Acronym: BPTB，Meniscus

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 28, 2025
Registry last updated: Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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