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Cartilage InjuryPhase 3NCT02993510

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

A Phase 3 study testing Microfracture, Chondro-Gide sutured and Chondro-Gide glued in people with Cartilage Injury and Osteochondritis Dissecans, run by Geistlich Pharma AG at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cartilage Injury, Osteochondritis Dissecans
What is being tested?
Microfracture, Chondro-Gide sutured and Chondro-Gide glued
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
7 sitesGermany
Study dates
Dec 2003to Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • University of Regensburg

    Bad Abbach

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Universitätsklinikum Giessen

    Giessen

  • Orthopedikum Hamburg

    Hamburg

  • Unfallklinik Hannover

    Hanover

  • University of Schleswig-Holstein

    Lübeck

  • Sportklinik Ravensburg

    Ravensburg

Other trials in Germany

About this study

Official title: 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.

Read the 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.
Being tested
Microfracture, Chondro-Gide sutured, Chondro-Gide glued
Keywords
microfracture, enhanced marrow stimulation, articular cartilage, Autologous Matrix-Induced Chondrogenesis, Chondro-Gide®, knee surgery, AMIC
Medical subject headings
Osteochondritis Dissecans, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MicrofractureProcedure or surgery

    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

Study groups in NCT02993510
Study groupRoleWhat they receive
microfractureActive comparatorMicrofracture 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
Receives: Procedure: Microfracture
Microfracture with Chondro-Gide suturedExperimentalMicrofracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
Receives: Device: Chondro-Gide sutured
Microfracture with Chondro-Gide gluedExperimentalMicrofracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
Receives: Device: Chondro-Gide glued

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years post-surgery

  2. 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).

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

Secondary outcomes (4)

  1. 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.

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

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

    The Change from Baseline will be evaluated.

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

  3. 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.

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

  4. Adverse Events (AE) Review

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

    Measured: 5 years post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study startDec 2003
  3. Primary completionDec 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993510
Sponsor's protocol ID
10830-003
Status last verified
Feb 2017
First submitted
2 Dec 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC(R)) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7:133-43. doi: 10.2174/1874325001307010133. Print 2013.

    PubMed 23730377

  • Volz M, Schaumburger J, Frick H, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop. 2017 Apr;41(4):797-804. doi: 10.1007/s00264-016-3391-0. Epub 2017 Jan 20.

    PubMed 28108777

  • Volz M, Schaumburger J, Gellissen J, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of autologous matrix-induced chondrogenesis (AMIC(R)) over microfracture: 10-year follow-up. Eur J Orthop Surg Traumatol. 2024 Jul;34(5):2429-2437. doi: 10.1007/s00590-024-03948-0. Epub 2024 Apr 17.

    PubMed 38630297

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Microfracture, Chondro-Gide sutured and Chondro-Gide glued in people with Cartilage Injury and Osteochondritis Dissecans, run by Geistlich Pharma AG at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993510, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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