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Not yet recruiting NCT07088094

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

No phase Interventional Meniscal Tears ACL - Anterior Cruciate Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bone-patellar tendon-bone or meniscus allograft transplantation techniques, Quasi-anatomical meniscus allograft transplantation.
Who it may be relevant to
Registry conditions: Meniscal Tears, ACL - Anterior Cruciate Ligament Rupture. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of Postoperative Complications Unit of Measure [Time frame: 2 years]
  • Functional Improvement in Knee Joint Unit of Measure-Knee Society Score (KSS) [Time frame: 2 years]
  • Functional Improvement in Knee Joint Unit of Measure-Lysholm Knee Score [Time frame: 2 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Jiang D, Ao YF, Gong X, Wang YJ, Luo H, Chen LX, Wang HJ, Xie X, Zhang JY, Yu JK. Double-bundle anterior cruciate ligament reconstruction using bone-patellar tendon-bone allograft: technique and 2- to 5-year follow-up. Am J Sports Med. 2012 May;40(5):1084-92. doi: 10.1177/0363546512440686. Epub 2012 Apr 2. PMID 22472270
  • Wang DY, Lee CA, Zhang B, Li YZ, Meng XY, Jiang D, Yu JK. The immediate meniscal allograft transplantation achieved better chondroprotection and less meniscus degeneration than the conventional delayed transplantation in the long-term. Knee Surg Sports Traumatol Arthrosc. 2022 Nov;30(11):3708-3717. doi: 10.1007/s00167-022-06982-9. Epub 2022 Apr 28. PMID 35484433

Identifiers

NCT: NCT07088094 · 25076-3-01 · 12110000318301495P

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗