Clinical trial NCT04960436: Clinical Effect of Allogeneic Meniscus Transplantation
Official title: Clinical Effect of Allogeneic Meniscus Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Lesion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2021-07-13
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Magnetic resonance imaging (MRI)
timeFrame: Before the operation
measure: Radiographs
timeFrame: 10 years after the operation
measure: Magnetic resonance imaging (MRI)
timeFrame: 10 years after the operation
measure: Radiographs
timeFrame: Before the operation
Secondary outcomes:
measure: visual analog scale (VAS) scores
timeFrame: Before and 10 to 15 years after the operation
measure: International Knee Documentation Committee (IKDC) score
timeFrame: Before and 10 to 15 years after the operation
measure: Tegner score
timeFrame: Before and 10 to 15 years after the operation
measure: Lysholm score
timeFrame: Before and 10 to 15 years after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jia-kuo Yu, Prof.
role: STUDY_CHAIR
References: