Meniscus Regeneration After Meniscectomy and Its Clinical Significance

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04959292
Collaborator
(none)
50
1
30
1.7

Study Details

Study Description

Brief Summary

Meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. Meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. Plenty of studies indicate that meniscus-deficiency increases the risk of OA and cause long-term poor outcomes.

Spontaneous human meniscus regeneration is rarely reported and whether regenerated meniscus is chondral-protective and can prevent OA progression remain unknown. During our clinical practice, we have encountered many cases with complete meniscal regeneration under arthroscopy. In this study, we will include all the patients who receiving meniscectomy and ACL reconstruction and knee arthroscopy 2 years after primary surgery. Patients demographic characters will be reviewed. The resected meniscus in the primary surgery and biopsied regenerated meniscus will be analyzed by histological and immunohistochemical method and their ultrastructure will be observed by electron microscope. Patients will be followed at 2-, 5- and 10-year after the primary surgery and the cartilage degeneration and OA progression will be assessed.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: arthroscopy

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Meniscus Regeneration After Meniscectomy: Factors Predicting the Regeneration and the Clinical Significance of the Regenerated Meniscus
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Meniscus regeneration

Reconstruction of the anterior cruciate ligament, total or partial meniscus resection was performed in our hospital, and two years after the operation, the meniscus regeneration was found under secondary arthroscopy.

Diagnostic Test: arthroscopy
arthroscopy

Meniscus without regeneration

Anterior cruciate ligament reconstruction, total or partial meniscus resection was performed in our hospital, and two years after the operation, no meniscus regeneration was found under secondary arthroscopy.

Diagnostic Test: arthroscopy
arthroscopy

Outcome Measures

Primary Outcome Measures

  1. meniscus regeneration [2 year]

    the resected meniscus regeneration is found under the arthroscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients intending to undergo single-knee ACL reconstruction at our Institute of Sports Medicine.

  2. The age of 18 ~ 50 years old at the time of operation.

  3. Both men and women.

  4. BMI < 24.

  5. Complete or partial meniscectomy was performed at the same time as ACL reconstruction.

  6. Patients willing to undergo a second arthroscopic exploration 2 years postoperatively and to take the portal screws used to fix the ligaments during the initial surgery.

  7. Patients with preserved meniscus video during ACL reconstruction.

  8. The degree of knee osteoarthritis (KOA) at the time of operation was < Ⅲ of Kellgren Laurence level.

Exclusion Criteria:
  1. Patients with severe knee cartilage injury.

  2. Patients with KOA≥KLⅢ at the time of operation.

  3. The patients cannot be followed up.

  4. Patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery.

  5. Patients with rheumatoid arthritis or other arthritis.

  6. Patients with other systemic diseases who take oral anti-inflammatory analgesics for years.

  7. Patients with multiple injections of drugs in the joint due to various reasons.

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

Investigators

  • Principal Investigator: Zimu Mao, Dortor, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04959292
Other Study ID Numbers:
  • M2019299
First Posted:
Jul 13, 2021
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2021