Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

NCT04537013 | Terminated DMC FDA Device

• 1 other identifier: 13575-237
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 15

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.

Conditions

Knee Injuries; Cartilage Injury; Cartilage Disease; Knee Discomfort

Keywords

Microfracture; Cartilage; Knee

Outcome Measures

Primary Outcomes (1)

• Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS

  The CCS is defined as a patient meeting all of the three following criteria: 1. Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up 2. Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up 3. Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion

  24 Months

Secondary Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

• Magnetic Resonance Observation of Cartilage Score

  3 months, 24 months

• Patient satisfaction

  6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

• Tegner Activity Scale

  6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

• Employment status

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Patients with small chondral lesions of the knee

Procedure: Microfracture

Investigational Group

EXPERIMENTAL

Patients with large chondral lesions of the knee

Device: Microfracture plus placement of Chondro-Gide® ACC

Interventions

Microfracture PROCEDURE

Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.

Control Arm

Microfracture plus placement of Chondro-Gide® ACC DEVICE

Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.

Investigational Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• BMI ≥ 30 kg/m2
• Symptomatic contralateral knee
• Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
• 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)
• Patella dysplasia
• Chronic inflammatory arthritis or infectious arthritis
• History of autoimmune disease or immunodeficiency
• History of connective tissue disease
• Intra-articular steroid use within the 3 months prior to enrollment
• Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
• The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
• Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
• Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
• Active infection of the index knee
• Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (15)

The MORE Foundation

Phoenix, Arizona, 85023, United States

Location

Orthopaedic Foundation

Stamford, Connecticut, 06905, United States

Location

Emory Sports Medicine Complex

Johns Creek, Georgia, 30097, United States

Location

Fraser Orthopaedic Institute

New Westminster, British Columbia, V3L 0E4, Canada

Location

University of Calgary

Calgary, CGY, T2N5A1, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Research Institute (SRI)

Toronto, Ontario, M4N 3M5, Canada

Location

University of Toronto Orthopaedics

Toronto, TOR, M5S 1B2, Canada

Location

Gelenkzentrum Mittelrhein GmbH

Mayen, Mayen, 63 D-56727, Germany

Location

Regio Kliniken GmbH

Pinneberg, Schleswig-Holstein, 25421, Germany

Location

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lübeck, Germany

Location

Orthopädische Chirurgie München

München, 81369, Germany

Location

Sportklinik Ravensburg

Ravensburg, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

MeSH Terms

Conditions

Knee Injuries; Cartilage Diseases; Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fractures, Bone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fabiana Martinelli

  Geistlich Pharma AG

  STUDY DIRECTOR

• Kevin Plancher, MD

  Plancher Orthopedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 3, 2020
• Study Start: August 26, 2020
• Primary Completion: September 25, 2025
• Study Completion: September 29, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); US (3); CA (6)