Clinical Effect of Allogeneic Meniscus Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Procedure: Meniscus Allograft Transplantation; Procedure: Meniscectomy

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before the operation
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.	Before the operation
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.	10 years after the operation
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.	10 years after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before and 10 to 15 years after the operation
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.	Before and 10 to 15 years after the operation
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.	Before and 10 to 15 years after the operation
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.	Before and 10 to 15 years after the operation

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2005
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 200506M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No