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

NCT ID: NCT04537013

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-26
• Study Completion Date: 2028-12-31

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.

Conditions

Knee Injuries; Cartilage Injury; Cartilage Disease; Knee Discomfort

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Arm

Patients with small chondral lesions of the knee

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

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

Investigational Group

Patients with large chondral lesions of the knee

Group Type: EXPERIMENTAL

Microfracture plus placement of Chondro-Gide® ACC

Intervention Type: 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.

Interventions

Microfracture

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

Intervention Type: PROCEDURE

Microfracture plus placement of Chondro-Gide® ACC

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabiana Martinelli

Role: STUDY_DIRECTOR

Geistlich Pharma AG

Kevin Plancher, MD

Role: PRINCIPAL_INVESTIGATOR

Plancher Orthopedics and Sports Medicine

Locations

The MORE Foundation

Phoenix, Arizona, United States

Orthopaedic Foundation

Stamford, Connecticut, United States

Emory Sports Medicine Complex

Johns Creek, Georgia, United States

Fraser Orthopaedic Institute

New Westminster, British Columbia, Canada

University of Calgary

Calgary, CGY, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Sunnybrook Research Institute (SRI)

Toronto, Ontario, Canada

University of Toronto Orthopaedics

Toronto, TOR, Canada

Gelenkzentrum Mittelrhein GmbH

Mayen, Mayen, Germany

Regio Kliniken GmbH

Pinneberg, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lübeck, , Germany

Orthopädische Chirurgie München

München, , Germany

Sportklinik Ravensburg

Ravensburg, , Germany

University Hospital Regensburg

Regensburg, , Germany

Countries

United States; Canada; Germany

Other Identifiers

13575-237

Identifier Type: -

Identifier Source: org_study_id