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
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Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-08-01
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bone-patellar tendon-bone allograft transplantation
Bone-patellar tendon-bone allograft transplantation
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。
Control group
non-surgical or conservative treatment group
No interventions assigned to this group
Quasi-anatomical meniscus allograft transplantation
Quasi-anatomical meniscus allograft transplantation
Quasi-anatomical meniscus allograft transplantation
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。
Quasi-anatomical meniscus allograft transplantation
Quasi-anatomical meniscus allograft transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
60 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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YujiakuoTHU
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
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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