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

Sponsor
Christian Candrian (Other)
Overall Status
Recruiting
CT.gov ID
NCT05053646
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
105.1
Anticipated Duration (Months)
40
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Meniscal repair
  • Procedure: Marrow venting procedure
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial
Actual Study Start Date :
Dec 29, 2021
Anticipated Primary Completion Date :
Oct 1, 2030
Anticipated Study Completion Date :
Oct 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Marrow venting arm

Meniscal suture associated with marrow venting procedure

Procedure: Meniscal 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.

Procedure: Marrow 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.
Active Comparator: Control arm

Meniscal suture alone, without marrow venting procedure

Procedure: Meniscal 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.

Outcome Measures

Primary Outcome Measures

  1. subjective International Knee Documentation Committee (IKDC) score [2 years]

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

Secondary Outcome Measures

  1. Objective International Knee Documentation Committee (IKDC) [(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) [(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 [(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) [(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) [(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 [(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 [1 year]

    Healing rate (MRI at 1 year)

  8. Treatment related adverse events [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. [6 weeks]

    Function curves during the first 6 weeks.

  10. Pain curves during the first 6 weeks. [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 [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ente Ospedaliero Cantonale Lugano Switzerland 6900
2 Clinica Ars Medica Lugano Switzerland

Sponsors and Collaborators

  • Christian Candrian

Investigators

  • Principal Investigator: Christian Candrian, MD, Ente Ospedaliero Cantonale, Bellinzona

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Christian Candrian, Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier:
NCT05053646
Other Study ID Numbers:
  • ORL-ORT-019
First Posted:
Sep 22, 2021
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 23, 2022