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

Last updated: February 20, 2017
Sponsor: Geistlich Pharma AG
Overall Status: Completed

Phase

3

Condition

Musculoskeletal Diseases

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT02993510
10830-003
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

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 meniscusresection, 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

Total Participants: 67
Study Start date:
December 01, 2003
Estimated Completion Date:
July 31, 2016

Study 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.

Connect with a study center

  • University of Regensburg

    Bad Abbach,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg,
    Germany

    Site Not Available

  • Universitätsklinikum Giessen

    Giessen,
    Germany

    Site Not Available

  • Orthopedikum Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Unfallklinik Hannover

    Hanover,
    Germany

    Site Not Available

  • University of Schleswig-Holstein

    Lubeck,
    Germany

    Site Not Available

  • Sportklinik Ravensburg

    Ravensburg,
    Germany

    Site Not Available

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