The Effectiveness of the Microfracture Technique in the Meniscal Healing

Sponsor
Hasanuddin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05799196
Collaborator
(none)
62
1
8
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Microfracture

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
62 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Effectiveness of the Microfracture Technique in the Meniscal Healing Rate in Patients With Meniscal Tear Among Indonesian Population
Anticipated Study Start Date :
Mar 31, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Healing Rate [3 months]

    Healing Rate, Investigated by MRI and Arthroscopy

  2. Healing Rate [6 months]

    Healing Rate, Investigated by MRI and Arthroscopy

Secondary Outcome Measures

  1. Functional Outcome [3 months]

    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.

  2. Functional Outcome [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hasanuddin University Makassar South Sulawesi Indonesia

Sponsors and Collaborators

  • Hasanuddin University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leonard Christianto Singjie, Principal Investigator, Hasanuddin University
ClinicalTrials.gov Identifier:
NCT05799196
Other Study ID Numbers:
  • HasanuddinU/Ortopedi/001
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leonard Christianto Singjie, Principal Investigator, Hasanuddin University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2023