The Effectiveness of the Microfracture Technique in the Meniscal Healing

NCT05799196 | Unknown

• 1 other identifier: HasanuddinU/Ortopedi/001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Meniscus injuries are a very common cause of knee pain. The meniscus is a semilunar fibrocartilage structure found on the medial and lateral sides of the knee. The meniscus serves to absorb impact and protect the articular cartilage during weight-bearing activities, joint stability, proprioception, and nutrition. This has a significant effect on knee biomechanics. After the menisci are injured, the biomechanics of the knee change so that degenerative changes occur more frequently in the tibiofemoral compartment. Improvement of tibiofemoral arthrosis after meniscectomy surgery has been demonstrated in several long-term clinical studies. With increasing awareness of the importance of the meniscus in knee biomechanics, various meniscus repair techniques have been developed. In addition, several adjuvants for healing have been proposed to enhance meniscus healing. However, a study showed the meniscal repair failure rate increased from 22% to 24% at 5 years. Study found the healing rate of meniscus repair, which was accompanied by ACL repair, had a greater healing rate, 93% vs. 50%. Hemarthrosis that occurs after bony tunneling during ACL reconstruction provides a fibrin clot and an environment rich in factors that promote healing of the newly repaired meniscus. The fibrin clot provides the structural foundation for meniscus healing. Transmission factors, such as fibronectin and growth factors, are also present. Microfracture is a common procedure used for the treatment of damage to the articular cartilage in the knee. This procedure is used to stimulate the production of fibrocartilage in areas of injured cartilage. Microfractures are performed by creating 1 or more small channels (1 to 3 mm in size) that pierce the subchondral bone and release bone-forming components into the joint. Microfractures serve to promote the formation of fibrocartilage over damaged cartilage. Research in 2016 used an animal model (Capra hircus) to investigate the effectiveness of the microfracture technique on meniscus tear healing rates. They found significant healing in meniscal repair accompanied by microfracture technique (65% vs 12%). However there is still not enough research regarding the efficacy of microfracture in meniscal healing, especially among Indonesian. Therefore, the investigators aim to investigate its efficacy.

Conditions

Microfractures; Meniscus Tear

Keywords

meniscus tear; microfracture

Outcome Measures

Primary Outcomes (2)

• Healing Rate

  Healing Rate, Investigated by MRI and Arthroscopy

  3 months

• Healing Rate

  Healing Rate, Investigated by MRI and Arthroscopy

  6 months

Secondary Outcomes (2)

• Functional Outcome

  3 months

• Functional Outcome

  6 months

Study Arms (2)

Microfracture

The patient with meniscus tear would be performed meniscus repair with additional microfracture

Procedure: Microfracture

Conventional

The patient with meniscus tear would be performed meniscus repair

Procedure: Microfracture

Interventions

Microfracture PROCEDURE

Microfracture was made in the non-weight bearing chondral to provide the release of MSC and growth factor.

Conventional; Microfracture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with meniscus tear in Wahidin Sudirohusodo General Hospital

You may qualify if:

• Patients with meniscus tears
• The patient underwent meniscus repair surgery using arthroscopy.
• Have an MRI examination before and after surgery within 6 months post-surgery.

You may not qualify if:

• Patients with meniscus tears in the white-white area
• The patient underwent meniscus repair surgery without using arthroscopy
• The patient did not perform an MRI examination before after surgery within 6 months post-surgery.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, Indonesia

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Muhammad Sakti, MD, Ph.D

  Hasanuddin University

  STUDY CHAIR

Central Study Contacts

Leonard Christianto Singjie, MD

CONTACT

+6281212609805; leonardcs@hotmail.co.id

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: March 31, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Locations

ID (1)