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

February 20, 2017 updated by: Geistlich Pharma AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Abbach, Germany
        • University of Regensburg
      • Freiburg, Germany
        • Universitatsklinikum Freiburg
      • Giessen, Germany
        • Universitätsklinikum Gießen
      • Hamburg, Germany
        • Orthopedikum Hamburg
      • Hanover, Germany
        • Unfallklinik Hannover
      • Lubeck, Germany
        • University of Schleswig-Holstein
      • Ravensburg, Germany
        • Sportklinik Ravensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
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
Experimental: Microfracture with Chondro-Gide sutured
Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
Device: Chondro-Gide sutured
Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
Experimental: Microfracture with Chondro-Gide glued
Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
Device: Chondro-Gide glued
Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 years post-surgery
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).
6 months and 1,2 and 5 years post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
Time Frame: 6 months and 1,2 and 5 years post-surgery
The Change from Baseline will be evaluated.
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".
Time Frame: 6 months and 1,2 and 5 years post-surgery
The Change from Baseline will be evaluated.
6 months and 1,2 and 5 years post-surgery
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.
5 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geistlich Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sven Anders, MD, University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10830-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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