Meniscal TearsBPTB，MeniscusNCT07088094

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

A study testing bone-patellar tendon-bone or meniscus allograft transplantation techniques and Quasi-anatomical meniscus allograft transplantation in people with Meniscal Tears and ACL - Anterior Cruciate Ligament Rupture, run by Beijing Tsinghua Chang Gung Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Meniscal Tears, ACL - Anterior Cruciate Ligament Rupture
What is being tested?: bone-patellar tendon-bone or meniscus allograft transplantation techniques and Quasi-anatomical meniscus allograft transplantation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 1 Aug 2025to 31 May 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

About this study

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.

Conditions: Meniscal Tears, ACL - Anterior Cruciate Ligament Rupture
Being tested: bone-patellar tendon-bone or meniscus allograft transplantation techniques, Quasi-anatomical meniscus allograft transplantation
Medical subject headings: Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bone-patellar tendon-bone or meniscus allograft transplantation techniquesProcedure or surgery
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 transplantationProcedure or surgery
Quasi-anatomical meniscus allograft transplantation

Study groups in NCT07088094
Study group	Role	What they receive
Bone-patellar tendon-bone allograft transplantation	Experimental	Bone-patellar tendon-bone allograft transplantation Receives: 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 Receives: Procedure: Quasi-anatomical meniscus allograft transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202531 May 2028

First posted28 Jul 2025
Study start1 Aug 2025 (estimated)
Primary completion31 May 2028 (estimated)
Study completion31 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Meniscal TearsStudies of the same condition, open and under way.
More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07088094
Sponsor's protocol ID: 25076-3-01
Other IDs: 12110000318301495P
Acronym: BPTB，Meniscus
Status last verified: Jul 2025
First submitted: 18 May 2025
Last updated: 28 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 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.
PubMed 35484433

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique
ClinicalTrials.gov ID: NCT07088094
Acronym / sponsor ID: BPTB，Meniscus / 25076-3-01
Conditions: Meniscal Tears, ACL - Anterior Cruciate Ligament Rupture
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
Study start: 1 Aug 2025 (estimated)
Primary completion: 31 May 2028 (estimated)
Study completion: 31 May 2028 (estimated)
First posted: 28 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Bone-patellar tendon-bone allograft transplantation	Experimental	Procedure: bone-patellar tendon-bone or meniscus allograft transplantation techniquesBone-patellar tendon-bone allograft transplantation
Control group	No intervention	–non-surgical or conservative treatment group
Quasi-anatomical meniscus allograft transplantation	Experimental	Procedure: Quasi-anatomical meniscus allograft transplantationQuasi-anatomical meniscus allograft transplantation

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bone-patellar tendon-bone or meniscus allograft transplantation techniquesThis clinical study follows an interventional design, focusing on the evaluation of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques。	Procedure or surgery	Bone-patellar tendon-bone allograft transplantation
Quasi-anatomical meniscus allograft transplantationQuasi-anatomical meniscus allograft transplantation	Procedure or surgery	Quasi-anatomical meniscus allograft transplantation

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Results publication: PubMed 22472270Jiang 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.
Results publication: PubMed 35484433Wang 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Postoperative Complications Unit of Measure (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07088094, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.