Meniscus Lesionmen_microNCT02323490
Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)
A study testing with microfractures and without microfractures in people with Meniscus Lesion, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- with microfractures and without microfractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 19 Aug 2013to Apr 2018
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complete vertical longitudinal tear > 10 mm in length
- Tear located in the vascular portion of the meniscus, only in red-white zone
- Unstable peripheral tear
- Single tear of the medial and/or lateral meniscus
- Meniscal injury 1 -18 month prior surgery
- Planned second step arthroscopy (ACL reconstruction)
- Skeletally mature patients 18-55 years of age
Who cannot join
- discoid meniscus
- arthritic changes (Kellgren Lawrence scale >2)
- non repairable meniscus
- degenerative or presence of crystals in meniscus
- concomitant procedure (acl reconstruction, microfracturing, trephination)
- inflammatory diseases (i.e. rheumatoid arthritis)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
Otwock, Woj. Mazowieckie, 05-400
About this study
Official title: Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.
This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Results of this study will help ascertain whether microfractures improve meniscal healing rates.
Read the detailed description
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.
- Conditions
- Meniscus Lesion
- Being tested
- with microfractures, without microfractures
- Keywords
- meniscus repair, bone marrow stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with microfracturesProcedure or surgery
following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively
without microfracturesProcedure or surgery
standard procedure meniscal repair without augmentation.
| Study group | Role | What they receive |
|---|---|---|
| with microfractures | Experimental | Standardized meniscal repair with bone marrow stimulation techniques (microfractures) Receives: Procedure: with microfractures |
| without microfractures | Placebo comparator | Standardized meniscal repair without augmentation Receives: Procedure: without microfractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second look arthroscopy (assessment of meniscal healing integrity during second look)
The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.
Measured: 8-18 weeks
Secondary outcomes (4)
Visual Analog Scale
Pain Visual Analog Scale.
Measured: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Knee injury and Osteoarthritis Outcome Score scale
Knee injury and Osteoarthritis Outcome Score
Measured: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
International Knee Documentation Committee - Subjective Knee Evaluation Form
International Knee Documentation Committee - Subjective Knee Evaluation Form
Measured: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start19 Aug 2013
- Primary completionFeb 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafał Kamiński, M.D. Ph.D., Principal investigator, SPSK Prof A. Gruca Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323490
- Sponsor's protocol ID
- men_micro
- Acronym
- men_micro
- Status last verified
- Jun 2018
- First submitted
- 17 Dec 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20.
PubMed 30902532
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT02323490
- Acronym / sponsor ID
- men_micro / men_micro
- Conditions
- Meniscus Lesion
- Keywords
- meniscus repair, bone marrow stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 19 Aug 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Results of this study will help ascertain whether microfractures improve meniscal healing rates.
Detailed description
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with microfractures | Experimental | Procedure: with microfracturesStandardized meniscal repair with bone marrow stimulation techniques (microfractures) |
| without microfractures | Placebo comparator | Procedure: without microfracturesStandardized meniscal repair without augmentation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Complete vertical longitudinal tear > 10 mm in length
- Tear located in the vascular portion of the meniscus, only in red-white zone
- Unstable peripheral tear
- Single tear of the medial and/or lateral meniscus
- Meniscal injury 1 -18 month prior surgery
Key exclusion criteria (6 listed)
- discoid meniscus
- arthritic changes (Kellgren Lawrence scale >2)
- non repairable meniscus
- degenerative or presence of crystals in meniscus
- concomitant procedure (acl reconstruction, microfracturing, trephination)
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 |
|---|---|---|
| with microfracturesfollowing meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively | Procedure or surgery | with microfractures |
| without microfracturesstandard procedure meniscal repair without augmentation. | Procedure or surgery | without microfractures |
Primary outcome
Second look arthroscopy (assessment of meniscal healing integrity during second look)
Time frame: 8-18 weeks
The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.
4 secondary outcomes
Visual Analog Scale
Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Knee injury and Osteoarthritis Outcome Score scale
Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
International Knee Documentation Committee - Subjective Knee Evaluation Form
Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Derived from this study: PubMed 30902532Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20.
- Individual participant dataSharing planned: Undecided
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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.
Rafał Kamiński, M.D. Ph.D. principal investigator
SPSK Prof A. Gruca Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with microfractures and without microfractures in people with Meniscus Lesion, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 6 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: finished, as of the sponsor's last update on 12 Jun 2018. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Second look arthroscopy (assessment of meniscal healing integrity during second look) (time frame: 8-18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323490, which also lists 1 linked publication.
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 12 Jun 2018.