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A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

NCT04840147 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2024-03-20

No results posted yet for this study

Summary

The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).

Conditions

  • Chondral Defect
  • Articular Cartilage Defect
  • Articular Cartilage Disorder of Knee

Interventions

DEVICE

JointRep®

JointRep® is a medical device based on a thermogel polymer (Chitosan) for the treatment of chondral lesions, which consists of an injectable aqueous composition that forms a solid and sticky hydrogel in situ within cartilage defect(s). JointRep® is composed of an injectable thermo-gelling aqueous composition. It is used in conjunction with a Bone Marrow Stimulation type of procedure like Microfracture.

PROCEDURE

Microfracture

Microfracture is a bone marrow stimulation type of procedure where after debridement of the damaged chondral tissue within the lesion, obtention of stable vertical margins and curettage of the entire calcified layer, multiple holes are created with a variety of instruments (awls, picks, microdills, nanofracture) to establish a communication with the subchondral bone to create a blood clot to elicit the natural healing process

Sponsors & Collaborators

  • Mobius Medical Pty Ltd.

    collaborator INDUSTRY

  • Oligo Medic Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Bruce Caldwell, MBBS, FRACS · Lingard Private Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840147 on ClinicalTrials.gov