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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04840147




Registration number
NCT04840147
Ethics application status
Date submitted
23/03/2021
Date registered
9/04/2021

Titles & IDs
Public title
A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,
Scientific title
A Randomized, Controlled, Comparative, Single-blinded, Multi-center Study Evaluating JointRep® and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle or Trochlea, The JMAC Trial.
Secondary ID [1] 0 0
JR001PMAUS01-2020
Universal Trial Number (UTN)
Trial acronym
JMAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chondral Defect 0 0
Articular Cartilage Defect 0 0
Articular Cartilage Disorder of Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - JointRep®
Treatment: Surgery - Microfracture

Experimental: Intervention - JointRep® plus microfracture

Other: Control - Microfracture alone


Treatment: Devices: 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.

Treatment: Surgery: 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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lesion fill.
Timepoint [1] 0 0
24-months post procedure.
Secondary outcome [1] 0 0
Visual Analogue Scale.
Timepoint [1] 0 0
Baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.
Secondary outcome [2] 0 0
T2 scores.
Timepoint [2] 0 0
12 and 24-months post procedure.
Secondary outcome [3] 0 0
Treatment failure.
Timepoint [3] 0 0
24-months post procedure.
Secondary outcome [4] 0 0
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint [4] 0 0
6 and 12 and 24-months post procedure.
Secondary outcome [5] 0 0
Tegner Activity Scale
Timepoint [5] 0 0
6 and 12 and 24-months post procedure.
Secondary outcome [6] 0 0
Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 (MOCART-2) score.
Timepoint [6] 0 0
6 and 12 and 24-months post procedure.
Secondary outcome [7] 0 0
Euro Quality of Life-5D (EQ-5D) instrument for measuring quality of life.
Timepoint [7] 0 0
6 and 12 and 24-months post procedure.
Secondary outcome [8] 0 0
Safety as Adverse Events related to the procedure
Timepoint [8] 0 0
Baseline to 24-months post procedure.

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Are currently abusing drugs or alcohol or have a history of the same within the last 12 months
* Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
* Are currently breastfeeding or planning to breastfeed any time during the course of the study
* Are currently a prisoner
* Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)
* Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation
* Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance

Intra-operative

Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:

* Have lesion(s) in the index knee that are not contained (intact shoulders) and/or exceed 7 cm² in total size after debridement for a single lesion and 10cm2 for more than one lesion, if within the same condyle or the trochlea. If only a single lesion suitable to be included is identified, it might be between 1-7cm2.
* Minor concomitant procedures are allowed such as, but not limited to:

1. Removal of loose bodies
2. Plica excision
3. Minor synovial removing
4. Minor chondroplasty (debridement)
5. Lysis of adhesions
6. Meniscal trimming/suturing which respects the exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
185
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Orthopaedics and Sports Medicine - Deakin
Recruitment hospital [2] 0 0
Sydney Knee Specialists - Kogarah
Recruitment hospital [3] 0 0
Lingard Private Hospital - Newcastle
Recruitment hospital [4] 0 0
Orthosports - Randwick
Recruitment hospital [5] 0 0
Cairns Orthopaedic Clinic - Parramatta Park
Recruitment hospital [6] 0 0
North Queensland Knee - Pimlico
Recruitment hospital [7] 0 0
Melbourne Orthopedic Group - Melbourne
Recruitment postcode(s) [1] 0 0
- Deakin
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Parramatta Park
Recruitment postcode(s) [6] 0 0
- Pimlico
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Oligo Medic Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Mobius Medical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Caldwell, MBBS, FRACS
Address 0 0
Lingard Private Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthias Schurhoff, MD
Address 0 0
Country 0 0
Phone 0 0
+13054919070
Fax 0 0
Email 0 0
mschurhoff@oligomedic.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04840147