MicrofracturesNCT05799196
The Effectiveness of the Microfracture Technique in the Meniscal Healing
An observational study of Microfractures and Meniscus Tear, run by Hasanuddin University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microfractures, Meniscus Tear
- What is being tested?
- Microfracture
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Mar 2023to 1 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with meniscus tear in Wahidin Sudirohusodo General Hospital
Who may be able to join
- 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.
- Exclusion Criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Hasanuddin University
Makassar, South Sulawesi
Leonard Christianto Singjie, MD, +628121260985, leonardcs@hotmail.co.id
About this study
Official title: 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.
Read more
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
- Being tested
- Microfracture
- Keywords
- meniscus tear, microfracture
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
Microfracture was made in the non-weight bearing chondral to provide the release of MSC and growth factor.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture | The patient with meniscus tear would be performed meniscus repair with additional microfracture Receives: Procedure: Microfracture | |
| Conventional | The patient with meniscus tear would be performed meniscus repair Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
Healing Rate, Investigated by MRI and Arthroscopy
Measured: 3 months
Healing Rate
Healing Rate, Investigated by MRI and Arthroscopy
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start31 Mar 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrofracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 62 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Christianto Singjie, Hasanuddin University
- Investigators
- Muhammad Sakti, MD, Ph.D, Study chair, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799196
- Sponsor's protocol ID
- HasanuddinU/Ortopedi/001
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Microfracture Technique in the Meniscal Healing Rate in Patients With Meniscal Tear Among Indonesian Population
- ClinicalTrials.gov ID
- NCT05799196
- Acronym / sponsor ID
- HasanuddinU/Ortopedi/001
- Conditions
- Microfractures, Meniscus Tear
- Keywords
- meniscus tear, microfracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture | – | Procedure: MicrofractureThe patient with meniscus tear would be performed meniscus repair with additional microfracture |
| Conventional | – | Procedure: MicrofractureThe patient with meniscus tear would be performed meniscus repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with meniscus tear in Wahidin Sudirohusodo General Hospital
Key inclusion criteria (7 listed)
- 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.
- Exclusion Criteria
- Patients with meniscus tears in the white-white area
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrofractureMicrofracture was made in the non-weight bearing chondral to provide the release of MSC and growth factor. | Procedure or surgery | Conventional, Microfracture |
Primary outcome
Healing Rate
Time frame: 3 months
Healing Rate, Investigated by MRI and Arthroscopy
Healing Rate
Time frame: 6 months
Healing Rate, Investigated by MRI and Arthroscopy
2 secondary outcomes
Functional Outcome
Time frame: 3 months
Functional Outcome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
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Comparison of Minced Cartilage Implantation Versus Microfracture for Acetabular Chondral Lesions Due to FAI (Femoro-acetabular Impingement)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Sakti, MD, Ph.D study chair
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microfractures and Meniscus Tear, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonard Christianto Singjie, MD (+6281212609805, leonardcs@hotmail.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.