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

NCT04840147 | Recruiting DMC

• 1 other identifier: JR001PMAUS01-2020
• Study Type: interventional
• Target: 185
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

Bone Marrow Stimulation; Microfracture; Matrix Augmented Bone Marrow Stimulation; Chitosan

Outcome Measures

Primary Outcomes (1)

• Lesion fill.

  Percentage of lesion fill measured by 3D quantitative Magnetic Resonance Imaging (qMRI).

  24-months post procedure.

Secondary Outcomes (8)

• Visual Analogue Scale.

  Baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.

• T2 scores.

  12 and 24-months post procedure.

• Treatment failure.

  24-months post procedure.

• Knee Injury and Osteoarthritis Outcome Score (KOOS).

  6 and 12 and 24-months post procedure.

• Tegner Activity Scale

  6 and 12 and 24-months post procedure.

Study Arms (2)

Intervention

EXPERIMENTAL

JointRep® plus microfracture

Device: JointRep®; Procedure: Microfracture

Control

OTHER

Microfracture alone

Procedure: Microfracture

Interventions

JointRep® DEVICE

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.

Intervention

Microfracture PROCEDURE

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

Also known as: Bone Marrow Stimulation

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18-65 years old
• Have one or two focal articular cartilage lesion(s) (ICRS Grade 3 or 4A) on the femoral condyles or trochlea of the index knee; patellar tracking must be normal if the index lesion(s) is on the trochlea. Individually, a lesion can be between 1-7cm2. If more than one lesion is present, the sum of the two lesions should not exceed 10cm2.
• Within 6 months prior to treatment, have a Magnetic Resonance Imaging (MRI) or arthroscopic confirmation of lesion(s) in the index knee.
• For patients older than 40 y.o, to have a radiological Kellgren and Lawrence (K\&L) grading from a standing knee radiograph taken less than 6 months previously, Grade 1 or
• If not, an actual test will be performed as part of the visit 1 procedures.
• Have a clinically stable knee, with no ligament deficiencies (\<5mm side-to-side difference on Lachman and varus/valgus stress testing \& Grade 0 or 1 on Pivot shift test) and the meniscal rims are intact (a maximum of 50% resection is allowed)
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• VAS pain great than or equal to 4 in the last week.
• Be willing and able to comply with all study procedures including all preoperative, post-operative and rehabilitation requirements
• If female and of child-bearing potential, must report double-barrier, contraceptive use (e.g. use of birth-control pill and condom) for at least 2 months prior to treatment and in the 12 months following treatment.
• If female and of child-bearing potential, have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the 12 months following treatment.

You may not qualify if:

• Have a Body Mass Index (BMI) \>35kg/m2
• Have more than two lesions (ICRS grade 3 or 4A) on any surface in the index knee
• Have "kissing" or opposing lesion(s) (ICRS grade 3 or 4A) of the condyle, tibia or patella in the index knee; additional linear lesions which bear Grade 3 or 4 characteristics may be acceptable if they are determined by the Investigator to be incidental, not clinically relevant, and consistent with the subject demographic
• Have malalignment of \>5 degrees varus or valgus in the index knee based on standard AP x-rays requiring an osteotomy
• Have had any surgical treatment for cartilage repair in the index knee within 1 year prior to treatment
• Have had intra-articular injections within 3 months in the index knee
• Have a diagnosis of a concomitant knee injury which may confound assessment of the index knee (e.g., important meniscal injury)
• Have significant pain emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) limb.
• Have known allergies to shellfish
• Have a known history of crystalloid or inflammatory arthropathy
• Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica)
• Have advanced musculoskeletal disease
• Have active coagulation disorders
• Are currently using antibiotics
• Are participating concurrently in another clinical investigation, or have participated in a clinical investigation within the last 90 days, or intend to participate in another clinical investigation during the course of the study

Sponsors & Collaborators

• Oligo Medic Pty Ltd: lead
• Mobius Medical Pty Ltd.: collaborator

Study Sites (8)

Canberra Orthopaedics and Sports Medicine

Deakin, Australian Capital Territory, Australia

RECRUITING

Sydney Knee Specialists

Kogarah, New South Wales, Australia

ACTIVE NOT RECRUITING

Lingard Private Hospital

Newcastle, New South Wales, Australia

RECRUITING

Orthosports

Randwick, New South Wales, Australia

RECRUITING

Cairns Orthopaedic Clinic

Parramatta Park, Queensland, Australia

RECRUITING

North Queensland Knee

Pimlico, Queensland, Australia

RECRUITING

Melbourne Orthopedic Group

Melbourne, Victoria, Australia

RECRUITING

Dartmouth General Hospital

Dartmouth, Nova Scotia, B2Y 4G8, Canada

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Bruce Caldwell, MBBS, FRACS

  Lingard Private Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Schurhoff, MD

CONTACT

+13054919070; mschurhoff@oligomedic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 9, 2021
• Study Start: September 22, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); AU (7)