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Completed

NCT Number: NCT02993510

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

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.

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Key information

Conditions

Cartilage Injury Bone Diseases Fractures, Bone Fractures, Stress Musculoskeletal Diseases Osteochondritis Osteochondritis Dissecans Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Regensburg, Bad Abbach, Germany

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microfracture

Procedure

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 sutured

Device

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

Chondro-Gide glued

Device

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

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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 outcomes

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

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

    The Change from Baseline will be evaluated.

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

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

    The Change from Baseline will be evaluated.

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

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

    The Change from Baseline will be evaluated.

  4. Adverse Events (AE) Review

    Time frame: 5 years post-surgery

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

Sponsors and collaborators

Lead sponsor

Geistlich Pharma AG

Industry

Registry information

Official study title

Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003

Important dates

Study start
2003
Primary completion
2015
Study completion
2016
First posted
Dec 15, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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