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CompletedNCT04960436Updated Jul 13, 2021

Clinical Effect of Allogeneic Meniscus Transplantation

An interventional study of Meniscus Allograft Transplantation and Meniscectomy in Meniscus Lesion, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to participants aged 16 Years to 46 Years. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 16 years 4 months after the study started (first participant enrolled Feb 2005, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
16 Years to 46 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Meniscus Lesion
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 46 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Meniscus Allograft Transplantation

    The patient underwent Meniscus Allograft Transplantation

    Procedure: Meniscus Allograft Transplantation

  • Active comparator
    Meniscectomy

    The patient underwent Meniscectomy

    Procedure: Meniscectomy

Interventions

  • ProcedureMeniscus Allograft Transplantation

    patients received surgery of Meniscus Allograft Transplantation

  • ProcedureMeniscectomy

    patients received surgery of Meniscectomy

06

What researchers measure

Primary outcomes

  1. Magnetic resonance imaging (MRI)

    All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare). Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients. Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of \<50%; grade 3 = partial-thickness defect of \>50% but \<100%; grade 4 = full-thickness cartilage loss). The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.

    Time frame: Before the operation

  2. Radiographs

    All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up. The radiograph of the total length of the lower limbs was used to evaluate alignment. In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height. The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing. In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.

    Time frame: 10 years after the operation

  3. Magnetic resonance imaging (MRI)

    All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare). Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients. Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of \<50%; grade 3 = partial-thickness defect of \>50% but \<100%; grade 4 = full-thickness cartilage loss). The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.

    Time frame: 10 years after the operation

  4. Radiographs

    All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up. The radiograph of the total length of the lower limbs was used to evaluate alignment. In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height. The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing. In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.

    Time frame: Before the operation

Secondary outcomes

  1. visual analog scale (VAS) scores

    visual analog scale (VAS) scores was applied to evaluate knee pain. 0 points means no pain, 10 points means severe pain.

    Time frame: Before and 10 to 15 years after the operation

  2. International Knee Documentation Committee (IKDC) score

    At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of the subjective and objective symptoms of the knee joint system.

    Time frame: Before and 10 to 15 years after the operation

  3. Tegner score

    This score is widely used by exercise assessors for patients with knee joint disease. This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.

    Time frame: Before and 10 to 15 years after the operation

  4. Lysholm score

    This score is often used together with the Tegner score. The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.

    Time frame: Before and 10 to 15 years after the operation

07

Study locations

1 site
  • Institute of Sports Medicine, Peking University Third Hospital
    Beijing, Beijing 100191, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04960436
Lead sponsor
Peking University Third Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Sponsor
First posted
Jul 13, 2021
Start date
Feb 1, 2005
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Jul 13, 2021

Study contacts

Jia-kuo Yu, Prof.
study chair · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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