The Effectiveness of the Microfracture Technique in the Meniscal Healing

The Effectiveness of the Microfracture Technique in the Meniscal Healing Rate in Patients With Meniscal Tear Among Indonesian Population

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.

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tear; Microfractures
• Intervention / Treatment: Procedure: Microfracture

• Study Type: Observational
• Enrollment (Anticipated): 62

Contacts and Locations

• Study Contact: Name: Leonard Christianto Singjie, MD; Phone Number: +6281212609805; Email: leonardcs@hotmail.co.id

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia
      • Recruiting
      • Hasanuddin University
      • Contact: Leonard Christianto Singjie, MD; Phone Number: +628121260985; Email: leonardcs@hotmail.co.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with meniscus tear in Wahidin Sudirohusodo General Hospital

Description

Inclusion Criteria

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

B. Exclusion Criteria

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Microfracture; The patient with meniscus tear would be performed meniscus repair with additional microfracture	Procedure: Microfracture; Microfracture was made in the non-weight bearing chondral to provide the release of MSC and growth factor.
Conventional; The patient with meniscus tear would be performed meniscus repair	Procedure: Microfracture; Microfracture was made in the non-weight bearing chondral to provide the release of MSC and growth factor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	Healing Rate, Investigated by MRI and Arthroscopy	3 months
Healing Rate	Healing Rate, Investigated by MRI and Arthroscopy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome	Functional Outcome assessed with IKDC ScoreFunctional Outcome assessed with IKDC Score. The higher the score, the higher the level of function and the lower the level of symptoms. A score of 100 suggests no limitation with activities of daily living or sports activities and the absence of symptoms.	3 months
Functional Outcome	Functional Outcome assessed with IKDC Score. The higher the score, the higher the level of function and the lower the level of symptoms. A score of 100 suggests no limitation with activities of daily living or sports activities and the absence of symptoms.	6 months

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Study Chair: Muhammad Sakti, MD, Ph.D, Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 31, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: microfracture; meniscus tear
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: HasanuddinU/Ortopedi/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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