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Meniscal TearNCT05053646

This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing

A study testing Meniscal repair and Marrow venting procedure in people with Meniscal Tear, run by Christian Candrian at 2 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of meniscal repair, allowing the patient a better recovery. Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Meniscal Tear
What is being tested?
Meniscal repair and Marrow venting procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesSwitzerland
Study dates
29 Dec 2021to 1 Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Arthroscopic confirmed suturable meniscal tears,
  • Monolateral meniscal tears,
  • 18-45 years,
  • BMI>18,5 and <35 kg/m2,
  • Ability to give informed consent by signature.

Who cannot join

  • Bilateral meniscal tears requiring treatment,
  • Associated ligament lesions requiring treatment,
  • Associated cartilage lesions (Outerbridge > 2),
  • Knee axis deformities requiring correction
  • Generalized ligamentous laxity,
  • Radiographic knee ostheoarthritis,
Show all 10Show fewer
  • Other reasons for knee pain,
  • Pregnant or lactating women,
  • Serious systemic diseases such as cardiac, hepatic or renal failure, rheumatic diseases, non-compensated diabetic, psychological illnesses, central or peripheral neurological diseases, and autoimmune diseases,
  • Enrolled in another ongoing clinical trial.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christian R Candrian, MD contact

+41918117029

RicercaOrtopedia.ORL@eoc.ch

Gabriela Induni-Lang contact

+41918117029

Gabriela.Induni-Lang@eoc.ch

Switzerland2 sites, 2 recruiting
  • Ente Ospedaliero Cantonale

    Lugano, 6900

    Christian Candrian, MD, +41 (0) 91 811 61 23, christian.candrian@eoc.ch

    Recruiting
  • Clinica Ars Medica

    Lugano

    Guido Garavaglia, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of meniscal repair, allowing the patient a better recovery.

Read the detailed description

Meniscal tears are one of the most common lesions of the knee and are a risk factor for the development of knee osteoarthritis. A meniscal tear commonly causes knee pain, stiffness, loss of function and sometimes catching or locking of the knee, affecting patients' ability to participate in their everyday activities. In case of ineffective conservative management, meniscal tears are treated with meniscectomy (partial or total) or meniscal repair, with the latter considered, when possible, the optimal choice.

Meniscal repair consists of a suture that juxtaposes the flaps of the injured meniscus to facilitate the healing of the tear. Unfortunately, meniscal healing capability is limited. A higher rate of meniscal tears healing has been documented in patients treated simultaneously with a meniscal repair and anterior cruciate ligament reconstruction. A surgical augmentation technique performing micro-fractures on the medial aspect of the lateral femoral condyle during meniscal repair surgery has been developed to mimic the beneficial effect of anterior cruciate ligament reconstruction on the joint environment. This technique has been successfully tested in preclinical studies, in human cohort studies and, recently, in a randomized control trial. However, these randomised controlled trials present some methodological weaknesses, such as a low number of included patients, and included only full-thickness vertical longitudinal tears in the red-red zone, the meniscal tears with the highest healing potential. The effect of additional micro-fractures on the healing capacity of meniscal tears involving the red-white zone has never been tested.

Conditions
Meniscal Tear
Being tested
Meniscal repair, Marrow venting procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meniscal repairProcedure or surgery

    The meniscus is trimmed with an arthroscopic punch followed by an electric shaver to expose the margins of the tear and remove damaged tissue. Vertical sutures are made using TRUESPAN™ Meniscal Repair System (DePuy Synthes) to approximate both the femoral and tibial surfaces of the torn meniscus.

  • Marrow venting procedureProcedure or surgery

    After meniscal repair, a bone marrow venting procedure will be performed: a 45° micro-fracture awl is repeatedly penetrated through the bone of the intercondylar notch at the PCL origin until marrow elements are seen to enter the joint.

Study groups in NCT05053646
Study groupRoleWhat they receive
Marrow venting armExperimentalMeniscal suture associated with marrow venting procedure
Receives: Procedure: Meniscal repair; Procedure: Marrow venting procedure
Control armActive comparatorMeniscal suture alone, without marrow venting procedure
Receives: Procedure: Meniscal repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. subjective International Knee Documentation Committee (IKDC) score

    evaluated subjective IKDC score 2-years after intervention in two groups

    Measured: 2 years

Secondary outcomes (11)
  1. Objective International Knee Documentation Committee (IKDC)

    Objective IKDC - International Knee Documentation Committee (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  2. Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  3. Knee Injury and Osteoarthritis Outcome Score - KOOS

    Knee Injury and Osteoarthritis Outcome Score - KOOS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  4. Pain 0-10 Numerical Rating Scale (NRS)

    Pain 0-10 numerical rating scale - NRS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  5. Function 0-10 Numerical Rating Scale (NRS)

    Function 0-10 numerical rating scale - NRS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  6. Tegner score

    Tegner score (prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    Measured: (prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  7. Healing rate

    Healing rate (MRI at 1 year)

    Measured: 1 year

  8. Treatment related adverse events

    Treatment related adverse events: overall, intra-operative, short- (<3 months), mid- (3 months, 2 years), long-term (>2 years) adverse events

    Measured: 5 years

  9. Function curves during the first 6 weeks.

    Function curves during the first 6 weeks.

    Measured: 6 weeks

  10. Pain curves during the first 6 weeks.

    Pain curves during the first 6 weeks as retrieved by the values produced with the EOC EMApp.

    Measured: 6 weeks

  11. Radiographic progression of knee osteoarthritis

    Radiographic progression of knee osteoarthritis (x-ray at 5 years)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start29 Dec 2021
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053646
Sponsor's protocol ID
ORL-ORT-019
Status last verified
Sep 2026
First submitted
22 Jul 2021
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahn JH, Kwon OJ, Nam TS. Arthroscopic repair of horizontal meniscal cleavage tears with marrow-stimulating technique. Arthroscopy. 2015 Jan;31(1):92-8. doi: 10.1016/j.arthro.2014.07.029. Epub 2014 Sep 18.

    PubMed 25242513
  • Briggs KK, Kocher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006 Apr;88(4):698-705. doi: 10.2106/JBJS.E.00339.

    PubMed 16595458
  • Bryant D, Dill J, Litchfield R, Amendola A, Giffin R, Fowler P, Kirkley A. Effectiveness of bioabsorbable arrows compared with inside-out suturing for vertical, reparable meniscal lesions: a randomized clinical trial. Am J Sports Med. 2007 Jun;35(6):889-96. doi: 10.1177/0363546506298582. Epub 2007 Mar 2.

    PubMed 17337726
  • Charles HC, Kraus VB, Ainslie M, Hellio Le Graverand-Gastineau MP. Optimization of the fixed-flexion knee radiograph. Osteoarthritis Cartilage. 2007 Nov;15(11):1221-4. doi: 10.1016/j.joca.2007.05.012. Epub 2007 Oct 31.

    PubMed 17977754
  • Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy. 2007 Aug;23(8):839-44. doi: 10.1016/j.arthro.2007.02.005.

    PubMed 17681205
  • de Girolamo L, Galliera E, Volpi P, Denti M, Dogliotti G, Quaglia A, Cabitza P, Corsi Romanelli MM, Randelli P. Why menisci show higher healing rate when repaired during ACL reconstruction? Growth factors release can be the explanation. Knee Surg Sports Traumatol Arthrosc. 2015 Jan;23(1):90-6. doi: 10.1007/s00167-013-2712-8. Epub 2013 Oct 22.

    PubMed 24146050
  • Dean CS, Chahla J, Matheny LM, Mitchell JJ, LaPrade RF. Outcomes After Biologically Augmented Isolated Meniscal Repair With Marrow Venting Are Comparable With Those After Meniscal Repair With Concomitant Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 May;45(6):1341-1348. doi: 10.1177/0363546516686968. Epub 2017 Feb 1.

    PubMed 28298056
  • Ding C, Martel-Pelletier J, Pelletier JP, Abram F, Raynauld JP, Cicuttini F, Jones G. Meniscal tear as an osteoarthritis risk factor in a largely non-osteoarthritic cohort: a cross-sectional study. J Rheumatol. 2007 Apr;34(4):776-84. Epub 2007 Mar 15.

    PubMed 17361984
  • Driscoll MD, Robin BN, Horie M, Hubert ZT, Sampson HW, Jupiter DC, Tharakan B, Reeve RE. Marrow stimulation improves meniscal healing at early endpoints in a rabbit meniscal injury model. Arthroscopy. 2013 Jan;29(1):113-21. doi: 10.1016/j.arthro.2012.06.023. Epub 2012 Nov 30.

    PubMed 23200846
  • Englund M, Guermazi A, Roemer FW, Aliabadi P, Yang M, Lewis CE, Torner J, Nevitt MC, Sack B, Felson DT. Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons: The Multicenter Osteoarthritis Study. Arthritis Rheum. 2009 Mar;60(3):831-9. doi: 10.1002/art.24383.

    PubMed 19248082
  • Englund M, Roemer FW, Hayashi D, Crema MD, Guermazi A. Meniscus pathology, osteoarthritis and the treatment controversy. Nat Rev Rheumatol. 2012 May 22;8(7):412-9. doi: 10.1038/nrrheum.2012.69.

    PubMed 22614907
  • Freedman KB, Nho SJ, Cole BJ. Marrow stimulating technique to augment meniscus repair. Arthroscopy. 2003 Sep;19(7):794-8. doi: 10.1016/s0749-8063(03)00695-9.

    PubMed 12966391
  • Howarth WR, Brochard K, Campbell SE, Grogan BF. Effect of Microfracture on Meniscal Tear Healing in a Goat (Capra hircus) Model. Orthopedics. 2016 Mar-Apr;39(2):105-10. doi: 10.3928/01477447-20160119-04. Epub 2016 Jan 25.

    PubMed 26811956
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Meniscal repair and Marrow venting procedure in people with Meniscal Tear, run by Christian Candrian 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian R Candrian, MD (+41918117029, RicercaOrtopedia.ORL@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

subjective International Knee Documentation Committee (IKDC) score (time frame: 2 years). 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 NCT05053646, which also lists 14 linked publications.

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 Sep 2026.

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