Clinical trial NCT05799196: The Effectiveness of the Microfracture Technique in the Meniscal Healing
Official title: The Effectiveness of the Microfracture Technique in the Meniscal Healing Rate in Patients With Meniscal Tear Among Indonesian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microfractures
Meniscus Tear
Keywords: meniscus tear
microfracture
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with meniscus tear in Wahidin Sudirohusodo General Hospital

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Healing Rate
timeFrame: 3 months
measure: Healing Rate
timeFrame: 6 months
Secondary outcomes:
measure: Functional Outcome
timeFrame: 3 months
measure: Functional Outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Hasanuddin University
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Muhammad Sakti, MD, Ph.D
role: STUDY_CHAIR
References: