RecruitingNot ApplicableNCT05053646

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

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


Sponsor

Christian Candrian

Enrollment

80 participants

Start Date

Dec 29, 2021

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 16 YearsMax Age: 50 Years

Inclusion Criteria5

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

Exclusion Criteria10

  • 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.

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Interventions

PROCEDUREMeniscal repair

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.

PROCEDUREMarrow venting 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.


Locations(2)

Ente Ospedaliero Cantonale

Lugano, Switzerland

Clinica Ars Medica

Lugano, Switzerland

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NCT05053646