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

NCT ID: NCT07088094

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-05-31

Brief Summary

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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

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Conditions

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Meniscal Tears ACL - Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bone-patellar tendon-bone allograft transplantation

Bone-patellar tendon-bone allograft transplantation

Group Type EXPERIMENTAL

bone-patellar tendon-bone or meniscus allograft transplantation techniques

Intervention Type PROCEDURE

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

Control group

non-surgical or conservative treatment group

Group Type NO_INTERVENTION

No interventions assigned to this group

Quasi-anatomical meniscus allograft transplantation

Quasi-anatomical meniscus allograft transplantation

Group Type EXPERIMENTAL

Quasi-anatomical meniscus allograft transplantation

Intervention Type PROCEDURE

Quasi-anatomical meniscus allograft transplantation

Interventions

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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。

Intervention Type PROCEDURE

Quasi-anatomical meniscus allograft transplantation

Quasi-anatomical meniscus allograft transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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YujiakuoTHU

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 22472270 (View on PubMed)

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.

Reference Type RESULT
PMID: 35484433 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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12110000318301495P

Identifier Type: OTHER

Identifier Source: secondary_id

25076-3-01

Identifier Type: -

Identifier Source: org_study_id

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