NCT07088094

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Aug 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Aug 2025May 2028

First Submitted

Initial submission to the registry

May 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

May 18, 2025

Last Update Submit

July 17, 2025

Conditions

Meniscal TearsACL - Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (3)

  • Incidence of Postoperative Complications Unit of Measure

    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.

    2 years

  • Functional Improvement in Knee Joint Unit of Measure-Knee Society Score (KSS)

    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.

    2 years

  • Functional Improvement in Knee Joint Unit of Measure-Lysholm Knee Score

    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.

    2 years

Study Arms (3)

Bone-patellar tendon-bone allograft transplantation

EXPERIMENTAL

Bone-patellar tendon-bone allograft transplantation

Procedure: bone-patellar tendon-bone or meniscus allograft transplantation techniques

Control group

NO INTERVENTION

non-surgical or conservative treatment group

Quasi-anatomical meniscus allograft transplantation

EXPERIMENTAL

Quasi-anatomical meniscus allograft transplantation

Procedure: Quasi-anatomical meniscus allograft transplantation

Interventions

bone-patellar tendon-bone or meniscus allograft transplantation techniquesPROCEDURE

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

Bone-patellar tendon-bone allograft transplantation
Quasi-anatomical meniscus allograft transplantationPROCEDURE

Quasi-anatomical meniscus allograft transplantation

Quasi-anatomical meniscus allograft transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 22472270RESULT

  • 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: 35484433RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2025

First Posted

July 28, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

July 28, 2025

Record last verified: 2025-07