Meniscus Regeneration After Meniscectomy and Its Clinical Significance

Meniscus Regeneration After Meniscectomy: Factors Predicting the Regeneration and the Clinical Significance of the Regenerated Meniscus

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.

Study Overview

• Status: Recruiting
• Conditions: Regeneration; Meniscus Rupture
• Intervention / Treatment: Diagnostic test: arthroscopy

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Zimu Mao, Doctor; Phone Number: 13331031448; Email: mzm@pku.edu.cn
• Study Contact Backup: Name: Jiakuo Yu, Professor; Phone Number: 13331031448

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all the patients receving meniscectomy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
meniscus regeneration	the resected meniscus regeneration is found under the arthroscopy.	2 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 11, 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 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: meniscus; regeneration; meniscectomy
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: M2019299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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