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

December 19, 2023 updated by: Christian Candrian

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Recruiting
        • Ente Ospedaliero Cantonale
        • Contact:
      • Lugano, Switzerland
        • Recruiting
        • Clinica Ars Medica
        • Contact:
          • Guido Garavaglia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective International Knee Documentation Committee (IKDC) score
Time Frame: 2 years
evaluated subjective IKDC score 2-years after intervention in two groups
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
(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)
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)
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)
(pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
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)
(pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
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)
(pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
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)
(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)
Healing rate
Time Frame: 1 year
Healing rate (MRI at 1 year)
1 year
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
5 years
Function curves during the first 6 weeks.
Time Frame: 6 weeks
Function curves during the first 6 weeks.
6 weeks
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.
6 weeks
Radiographic progression of knee osteoarthritis
Time Frame: 5 years
Radiographic progression of knee osteoarthritis (x-ray at 5 years)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Candrian

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ORL-ORT-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meniscal Tear

Clinical Trials on Meniscal repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe