A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

Geistlich Pharma

Status and phase: Completed; Phase 3

Conditions: Cartilage Injury; Osteochondritis Dissecans

Treatments: Device: Chondro-Gide glued; Device: Chondro-Gide sutured; Procedure: Microfracture

Study type: Interventional

Funder types: Industry

Identifiers

NCT02993510

10830-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

Full description

• Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
• All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
• Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
• All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
• Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
• Measures to assess effectiveness and safety will be conducted at all follow-ups.
• Safety will be assessed by the collection of adverse events at all timepoints.

Enrollment: 67 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female between 18 and 50
• One or two cartilage defects Grade III or IV according to Outerbridge classification
• Defect size between 2 and 10 cm2 (inclusive)
• Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
• Informed consent
• Patient willing to fulfill a strict postoperative physiotherapy scheme

Exclusion criteria

• More than 2 defects
• Defects on both knees
• X-ray signs of osteoarthritis
• Bone lesion > 0.7 cm in the defect
• Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
• Rheumatoid, infectious disease
• Skin lesion on the operated knee
• Treatment with cartilage building medication
• Drug and alcohol abuse
• Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
• Pregnancy or lactation
• Collagen allergy
• Participation in other Trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 3 patient groups

microfracture

Active Comparator group

Description:

Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair

Treatment:

Procedure: Microfracture

Microfracture with Chondro-Gide sutured

Experimental group

Description:

Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure

Treatment:

Device: Chondro-Gide sutured

Microfracture with Chondro-Gide glued

Experimental group

Description:

Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure

Treatment:

Device: Chondro-Gide glued