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

Phase 3

Completed

• Conditions: Cartilage Injury; Osteochondritis Dissecans
• Interventions: Procedure: Microfracture; Device: Chondro-Gide glued; Device: Chondro-Gide sutured

• Registration Number: NCT02993510
• Lead Sponsor: Geistlich Pharma AG

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2015-12
• Study Completion: 2016-07
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microfracture	Microfracture	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
Microfracture with Chondro-Gide glued	Chondro-Gide glued	Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
Microfracture with Chondro-Gide sutured	Chondro-Gide sutured	Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure

Primary Outcome Measures

Name	Time	Method
Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years	2 years post-surgery	The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
MRI (magnetic resonance imaging) assessment of structural repair parameters.	6 months and 1,2 and 5 years post-surgery	Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.	6 months and 1,2 and 5 years post-surgery	The Change from Baseline will be evaluated.
Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).	6 months and 1,2 and 5 years post-surgery	The Change from Baseline will be evaluated.
Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".	6 months and 1,2 and 5 years post-surgery	The Change from Baseline will be evaluated.
Adverse Events (AE) Review	5 years post-surgery	The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.

Trial Locations

Locations (7)

Unfallklinik Hannover; 🇩🇪 Hanover, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Sportklinik Ravensburg; 🇩🇪 Ravensburg, Germany

University of Regensburg; 🇩🇪 Bad Abbach, Germany

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

University of Schleswig-Holstein; 🇩🇪 Lubeck, Germany

Orthopedikum Hamburg; 🇩🇪 Hamburg, Germany