Clinical Effect of Allogeneic Meniscus Transplantation

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04960436
Collaborator
The First Affiliated Hospital of Anhui Medical University (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
38
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Meniscus Allograft Transplantation
  • Procedure: Meniscectomy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Effect of Allogeneic Meniscus Transplantation
Actual Study Start Date :
Feb 1, 2005
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Meniscus Allograft Transplantation

The patient underwent Meniscus Allograft Transplantation

Procedure: Meniscus Allograft Transplantation
patients received surgery of Meniscus Allograft Transplantation

Active Comparator: Meniscectomy

The patient underwent Meniscectomy

Procedure: Meniscectomy
patients received surgery of Meniscectomy

Outcome Measures

Primary Outcome Measures

  1. Magnetic resonance imaging (MRI) [Before the operation]

    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.

  2. Radiographs [10 years after the operation]

    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.

  3. Magnetic resonance imaging (MRI) [10 years after the operation]

    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.

  4. Radiographs [Before the operation]

    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.

Secondary Outcome Measures

  1. visual analog scale (VAS) scores [Before and 10 to 15 years after the operation]

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

  2. International Knee Documentation Committee (IKDC) score [Before and 10 to 15 years after the operation]

    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.

  3. Tegner score [Before and 10 to 15 years after the operation]

    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.

  4. Lysholm score [Before and 10 to 15 years after the operation]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 46 Years
Sexes Eligible for Study:
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:

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Sports Medicine, Peking University Third Hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University Third Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Study Chair: Jia-kuo Yu, Prof., Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04960436
Other Study ID Numbers:
  • 200506M
First Posted:
Jul 13, 2021
Last Update Posted:
Jul 13, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 13, 2021