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

NCT02993510 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

  • Cartilage Injury
  • Osteochondritis Dissecans

Interventions

PROCEDURE

Microfracture

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

DEVICE

Chondro-Gide sutured

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

DEVICE

Chondro-Gide glued

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

Sponsors & Collaborators

  • Geistlich Pharma AG

    lead INDUSTRY

Principal Investigators

  • Sven Anders, MD · University of Regensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2015-12-31
Completion
2016-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02993510 on ClinicalTrials.gov