Meniscus LesionNCT03968029
Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Avascular Area
A study testing suturing meniscal augmented and suturing meniscal in people with Meniscus Lesion, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping) Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- suturing meniscal augmented and suturing meniscal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Jul 2017to 31 Dec 2025
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic or traumatic tears of medial or lateral meniscus;
- Tearing affecting: only 2/3 central (= avascular zone) over more than 1 cm OR extending from the peripheral third (= vascularized area) within the avascular zone over more than 1 cm. In this case, preservation of the peripheral third over a width of at least 4 mm from the capsule;
- Single or multiple tears.
Who cannot join
- Meniscal tears that can not be sutured, reduced / approximated
- Tear creating a meniscal root avulsion
- Partial meniscal tears
- Meniscal tears already sutured
- Cartilage damage in the compartment> grade 2 (ICRS classification)
- Mechanical axis (varus / valgus) ≥ 2 °
Show all 13Show fewer
- Untreated ligament deficiency
- Osteotomy and / or concomitant ligament reconstruction, with the exception of ACL reconstruction.
- Compromised general health condition (score ASA score> 2)
- BMI ≥30
- Active smoking, drug use
- Allergy to porcine collagen
- Poor compliance
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, 1011
Dr Robin MARTIN
Lausanne, Canton of Vaud, 1011
About this study
Official title: Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
Read the detailed description
Historically, meniscus was considered as none essential for knee joint, and its removal by meniscectomy was the first-line treatment. Many studies have shown a negative progress towards osteoarthritis after meniscus ablation. This approach has gradually changed to preserve this meniscal capital, making way for new treatments as sutures. However the vascular organization of the meniscus is crucial for its cure. The healing potential of lesions in the meniscus non-vascularised aera is considered insufficient, and are often treated by a partial meniscectomy, resulting in a high risk of osteoarthritis. It appears therefore necessary to develop new strategies, as meniscal wrapping, to preserve meniscus presenting this type of damage.
- Conditions
- Meniscus Lesion
- Being tested
- suturing meniscal augmented, suturing meniscal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturing meniscal augmentedProcedure or surgery
Also called meniscal wrapping
meniscal tear sutured + bone marrow injection/collagen membrane
suturing meniscalProcedure or surgery
meniscal tear sutured
| Study group | Role | What they receive |
|---|---|---|
| Suturing meniscal augmented | Experimental | Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide) Receives: Procedure: suturing meniscal augmented |
| Suturing meniscal | Active comparator | Non-vascularised area meniscus tear was only sutured Receives: Procedure: suturing meniscal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in integrity and healing of meniscus repair
Arthrography (arthro-CT)
Measured: 12 and 24 months after treatment
Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery
Measured: baseline and 3, 12 and 24 months after treatment
International Knee Documentation Committee Score (IKDC)
Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery
Measured: baseline and 3, 12 and 24 months after treatment
SF-12 Survey
Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery
Measured: baseline and 3, 12 and 24 months after treatment
Failure rate
Number of readmission for meniscus tear
Measured: up to 24 months
Secondary outcomes (2)
Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)
Imaging: MRI
Measured: 12 months after treatment
Rate of suture type-associated complications
Post-operative data collection: inflammation, pain, recurrent tear of the meniscus, instability or stiffness joint, perimeniscal cyst formation, hemarthrosis or effusion.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start18 Jul 2017
- Primary completion19 Mar 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois
- Investigators
- Robin MARTIN, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968029
- Sponsor's protocol ID
- MW_OTR
- Status last verified
- Mar 2026
- First submitted
- 10 May 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT03968029
- Acronym / sponsor ID
- MW_OTR
- Conditions
- Meniscus Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 May 2019 (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.
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
Detailed description
Historically, meniscus was considered as none essential for knee joint, and its removal by meniscectomy was the first-line treatment. Many studies have shown a negative progress towards osteoarthritis after meniscus ablation. This approach has gradually changed to preserve this meniscal capital, making way for new treatments as sutures. However the vascular organization of the meniscus is crucial for its cure. The healing potential of lesions in the meniscus non-vascularised aera is considered insufficient, and are often treated by a partial meniscectomy, resulting in a high risk of osteoarthritis. It appears therefore necessary to develop new strategies, as meniscal wrapping, to preserve meniscus presenting this type of damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suturing meniscal augmented | Experimental | Procedure: suturing meniscal augmentedNon-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide) |
| Suturing meniscal | Active comparator | Procedure: suturing meniscalNon-vascularised area meniscus tear was only sutured |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Symptomatic or traumatic tears of medial or lateral meniscus;
- Tearing affecting: only 2/3 central (= avascular zone) over more than 1 cm OR extending from the peripheral third (= vascularized area) within the avascular zone over more than 1 cm. In this case, preservation of the peripheral third over a width of at least 4 mm from the capsule;
- Single or multiple tears.
Key exclusion criteria (13 listed)
- Meniscal tears that can not be sutured, reduced / approximated
- Tear creating a meniscal root avulsion
- Partial meniscal tears
- Meniscal tears already sutured
- Cartilage damage in the compartment> grade 2 (ICRS classification)
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 |
|---|---|---|
| suturing meniscal augmentedAlso: meniscal wrappingmeniscal tear sutured + bone marrow injection/collagen membrane | Procedure or surgery | Suturing meniscal augmented |
| suturing meniscalmeniscal tear sutured | Procedure or surgery | Suturing meniscal |
Primary outcome
Change in integrity and healing of meniscus repair
Time frame: 12 and 24 months after treatment
Arthrography (arthro-CT)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline and 3, 12 and 24 months after treatment
Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery
International Knee Documentation Committee Score (IKDC)
Time frame: baseline and 3, 12 and 24 months after treatment
Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery
SF-12 Survey
Time frame: baseline and 3, 12 and 24 months after treatment
Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery
Failure rate
Time frame: up to 24 months
Number of readmission for meniscus tear
2 secondary outcomes
Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)
Time frame: 12 months after treatment
Rate of suture type-associated complications
Time frame: up to 24 months
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 11 Mar 2026.
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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.
Robin MARTIN, MD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suturing meniscal augmented and suturing meniscal in people with Meniscus Lesion, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
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 3 inclusion and 13 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
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?
Change in integrity and healing of meniscus repair (time frame: 12 and 24 months after treatment). The study lists 5 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 11 Mar 2026.