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Trial record 16 of 23 for:    Osteochondritis Dissecans

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

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ClinicalTrials.gov Identifier: NCT02993510
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Geistlich Pharma AG

Brief 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.

Condition or disease Intervention/treatment Phase
Cartilage Injury Osteochondritis Dissecans Procedure: Microfracture Device: Chondro-Gide sutured Device: Chondro-Gide glued Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003
Study Start Date : December 2003
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993510


Locations
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Germany
University of Regensburg
Bad Abbach, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Universitätsklinikum Giessen
Giessen, Germany
Orthopedikum Hamburg
Hamburg, Germany
Unfallklinik Hannover
Hanover, Germany
University of Schleswig-Holstein
Lubeck, Germany
Sportklinik Ravensburg
Ravensburg, Germany
Sponsors and Collaborators
Geistlich Pharma AG
Investigators
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Principal Investigator: Sven Anders, MD University of Regensburg

Publications of Results:
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Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT02993510     History of Changes
Other Study ID Numbers: 10830-003
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geistlich Pharma AG:
microfracture
enhanced marrow stimulation
articular cartilage
Autologous Matrix-Induced Chondrogenesis
Chondro-Gide®
knee surgery
AMIC

Additional relevant MeSH terms:
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Fractures, Stress
Osteochondritis
Osteochondritis Dissecans
Fractures, Bone
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases