Clinical trial NCT04537013: Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
Official title: A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Injuries
Cartilage Injury
Cartilage Disease
Knee Discomfort
Keywords: Microfracture
Cartilage
Knee
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

Detailed description: The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
3. Between 18 and 55 years of age
4. Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol

Exclusion Criteria:

1. BMI ≥ 30 kg/m2
2. Symptomatic contralateral knee
3. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
4. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
5. Patella dysplasia
6. Chronic inflammatory arthritis or infectious arthritis
7. History of autoimmune disease or immunodeficiency
8. History of connective tissue disease
9. Intra-articular steroid use within the 3 months prior to enrollment
10. Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
11. The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
12. Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
13. Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
14. Active infection of the index knee
15. Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
16. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
17. History or current substance or alcohol abuse as defined by the DSM-V
18. Any other medical condition that the investigator determines would interfere with the validity of the study
19. Known allergy to porcine collagen
20. Symptom duration greater than 36 months

Primary outcomes:
measure: Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
timeFrame: 24 Months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Magnetic Resonance Observation of Cartilage Score
timeFrame: 3 months, 24 months
measure: Patient satisfaction
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Tegner Activity Scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Employment status
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The MORE Foundation
state: Arizona
city: Stamford
country: United States
facility: Orthopaedic Foundation
state: Connecticut
city: Johns Creek
country: United States
facility: Emory Sports Medicine Complex
state: Georgia
city: New Westminster
country: Canada
facility: Fraser Orthopaedic Institute
state: British Columbia
city: Calgary
country: Canada
facility: University of Calgary
state: CGY
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute (SRI)
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Orthopaedics
state: TOR
city: Pinneberg
country: Germany
facility: Regio Kliniken GmbH
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein Campus Lübeck
city: Mayen
country: Germany
facility: Gelenkzentrum Mittelrhein GmbH
city: München
country: Germany
facility: Orthopädische Chirurgie München
city: Ravensburg
country: Germany
facility: Sportklinik Ravensburg
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: Geistlich Pharma AG
name: Fabiana Martinelli
role: STUDY_DIRECTOR
affiliation: Plancher Orthopedics and Sports Medicine
name: Kevin Plancher, MD
role: PRINCIPAL_INVESTIGATOR
References: