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

Geistlich Pharma AG67 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cartilage Injury Osteochondritis Dissecans

Interventions

MicrofracturePROCEDURE

Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot

Chondro-Gide suturedDEVICE

Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy

Chondro-Gide gluedDEVICE

Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

University of Regensburg

Bad Abbach, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsklinikum Giessen

Giessen, Germany

Orthopedikum Hamburg

Hamburg, Germany

Outcomes

Primary Outcomes

Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years

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

Time frame: 2 years post-surgery

MRI (magnetic resonance imaging) assessment of structural repair parameters.

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).

Time frame: 6 months and 1,2 and 5 years post-surgery

Secondary Outcomes

Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.

The Change from Baseline will be evaluated.

Time frame: 6 months and 1,2 and 5 years post-surgery

Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).

The Change from Baseline will be evaluated.

Time frame: 6 months and 1,2 and 5 years post-surgery

Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".

The Change from Baseline will be evaluated.

Time frame: 6 months and 1,2 and 5 years post-surgery

Adverse Events (AE) Review

The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.