Clinical Effect of Allogeneic Meniscus Transplantation

NCT ID: NCT04960436

Last Updated: 2021-07-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-01

Study Completion Date

2021-04-01

Brief Summary

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In this study, patients who underwent allogeneic meniscus transplantation and meniscus resection were followed up for more than 10years to evaluate the long-term efficacy and explore the cartilage protective role of meniscus transplantation.

Detailed Description

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To investigate the long-term clinical effect of allogeneic meniscus transplantation, IKDC score, Lysholom score, Tegner score, VAS score, etc. were used to compare the clinical effects of allogeneic meniscus transplantation, and the progress of knee joint degeneration and cartilage injury was evaluated through X-ray and MRI.

Conditions

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Meniscus Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Meniscus Allograft Transplantation

The patient underwent Meniscus Allograft Transplantation

Group Type EXPERIMENTAL

Meniscus Allograft Transplantation

Intervention Type PROCEDURE

patients received surgery of Meniscus Allograft Transplantation

Meniscectomy

The patient underwent Meniscectomy

Group Type ACTIVE_COMPARATOR

Meniscectomy

Intervention Type PROCEDURE

patients received surgery of Meniscectomy

Interventions

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Meniscus Allograft Transplantation

patients received surgery of Meniscus Allograft Transplantation

Intervention Type PROCEDURE

Meniscectomy

patients received surgery of Meniscectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

The age is less than 50 years; the force line is basically normal (≤ ± 3°); the joint is stable or the joint stability is corrected at the same time during the operation; the joint degeneration or large area cartilage damage. In the transplantation group, 10 patients experienced pain or swelling in the joint space of the affected side for an average of 35 months after meniscus resection, and then received meniscus transplantation. The other 8 patients underwent meniscus transplantation at the same time as meniscus resection. Patients in the resection group received meniscus transplantation at the same time. Symptoms, signs, and magnetic resonance imaging (MRI) were diagnosed as a meniscus tear and the judgment during the operation could not be preserved, so a total meniscus was performed.

Exclusion Criteria

Severe knee synovial disease; severe joint degeneration or extensive cartilage damage; improper force lines; severely unstable joints that cannot be corrected; both meniscuses are removed; the other knee joint has a history of severe trauma or surgery.
Minimum Eligible Age

16 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jia-kuo Yu, Prof.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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200506M

Identifier Type: -

Identifier Source: org_study_id

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