Health TrialsbyHealthPanel

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

ConditionMeniscal Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-50
SponsorChristian Candrian

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Arthroscopic confirmed suturable meniscal tears,

Monolateral meniscal tears,

18-45 years,

BMI>18,5 and <35 kg/m2,

Disqualifiers

Bilateral meniscal tears requiring treatment,

Associated ligament lesions requiring treatment,

Associated cartilage lesions (Outerbridge > 2),

Knee axis deformities requiring correction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meniscal repair

    Procedure/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 procedure

    Procedure/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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Marrow venting armExperimental treatment 2 interventions
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

subjective International Knee Documentation Committee (IKDC) score

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

Time frame
2 years

Secondary outcomes

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)

Time frame
(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)

Time frame
(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)

Time frame
(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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Candrian

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Source ClinicalTrials.gov
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