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NCT Number: NCT05053646

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

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.

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Key information

Conditions

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Ars Medica, Lugano, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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.

Treatment and study plan

Meniscal repair

Procedure

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 procedure

Procedure

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.

Primary outcomes

  1. subjective International Knee Documentation Committee (IKDC) score

    Time frame: 2 years

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

Secondary outcomes

  1. Objective International Knee Documentation Committee (IKDC)

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

    Objective IKDC - International Knee Documentation Committee (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)

    Time frame: (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)

  3. Knee Injury and Osteoarthritis Outcome Score - KOOS

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

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

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

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

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

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

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

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

  6. Tegner score

    Time frame: (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)

    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)

  7. Healing rate

    Time frame: 1 year

    Healing rate (MRI at 1 year)

  8. Treatment related adverse events

    Time frame: 5 years

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

  9. Function curves during the first 6 weeks.

    Time frame: 6 weeks

    Function curves during the first 6 weeks.

  10. Pain curves during the first 6 weeks.

    Time frame: 6 weeks

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

  11. Radiographic progression of knee osteoarthritis

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian R Candrian, MD

CONTACT

[email protected]

+41918117029

Gabriela Induni-Lang

CONTACT

[email protected]

+41918117029

Sponsors and collaborators

Lead sponsor

Christian Candrian

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Sep 22, 2021
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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