Meniscus Regeneration After Meniscectomy and Its Clinical Significance

NCT04959292 | Unknown

• 1 other identifier: M2019299
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Rupture; Regeneration

Keywords

meniscus; regeneration; meniscectomy

Outcome Measures

Primary Outcomes (1)

• meniscus regeneration

  the resected meniscus regeneration is found under the arthroscopy.

  2 year

Study Arms (2)

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

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

Interventions

arthroscopy DIAGNOSTIC_TEST

arthroscopy

Meniscus regeneration; Meniscus without regeneration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

all the patients receving meniscectomy

You may qualify if:

• Patients intending to undergo single-knee ACL reconstruction at our Institute of Sports Medicine.
• The age of 18 \~ 50 years old at the time of operation.
• Both men and women.
• BMI \< 24.
• Complete or partial meniscectomy was performed at the same time as ACL reconstruction.
• 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.
• Patients with preserved meniscus video during ACL reconstruction.
• The degree of knee osteoarthritis (KOA) at the time of operation was \< Ⅲ of Kellgren Laurence level.

You may not qualify if:

• Patients with severe knee cartilage injury.
• Patients with KOA≥KLⅢ at the time of operation.
• The patients cannot be followed up.
• Patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery.
• Patients with rheumatoid arthritis or other arthritis.
• Patients with other systemic diseases who take oral anti-inflammatory analgesics for years.
• Patients with multiple injections of drugs in the joint due to various reasons.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

resected meniscus and biopsy of regenerated meniscus

MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Zimu Mao, Dortor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zimu Mao, Doctor

CONTACT

13331031448; mzm@pku.edu.cn

Jiakuo Yu, Professor

CONTACT

13331031448

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 13, 2021
• Study Start: June 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)