The Effectiveness of the Microfracture Technique in the Meniscal Healing

Meniscus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799196
• Other study ID #: HasanuddinU/Ortopedi/001
• Status: Recruiting
• Start date: March 31, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Hasanuddin University
• Contact: Leonard Christianto Singjie, MD
• Phone: +6281212609805
• Email: leonardcs[@]hotmail.co.id
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Stress
• Meniscus Tear
• Microfractures

Intervention

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

Locations

Country	Name	City	State
Indonesia	Hasanuddin University	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Rate	Healing Rate, Investigated by MRI and Arthroscopy	3 months
Primary	Healing Rate	Healing Rate, Investigated by MRI and Arthroscopy	6 months
Secondary	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
Secondary	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