Clinical Effect of Allogeneic Meniscus Transplantation

NCT04960436 | Completed

• 1 other identifier: 200506M
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Lesion

Outcome Measures

Primary Outcomes (4)

• 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.

  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

• 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

Secondary Outcomes (4)

• visual analog scale (VAS) scores

  Before and 10 to 15 years after the operation

• International Knee Documentation Committee (IKDC) score

  Before and 10 to 15 years after the operation

• Tegner score

  Before and 10 to 15 years after the operation

• Lysholm score

  Before and 10 to 15 years after the operation

Study Arms (2)

Meniscus Allograft Transplantation

EXPERIMENTAL

The patient underwent Meniscus Allograft Transplantation

Procedure: Meniscus Allograft Transplantation

Meniscectomy

ACTIVE COMPARATOR

The patient underwent Meniscectomy

Procedure: Meniscectomy

Interventions

Meniscus Allograft Transplantation PROCEDURE

patients received surgery of Meniscus Allograft Transplantation

Meniscus Allograft Transplantation

Meniscectomy PROCEDURE

patients received surgery of Meniscectomy

Meniscectomy

Eligibility Criteria

• Age: 16 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Meniscectomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Jia-kuo Yu, Prof.

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 13, 2021
• Study Start: February 1, 2005
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-06

Locations

CN (1)