Trial document




drksid header

  DRKS00009703

Trial Description

start of 1:1-Block title

Title

Postmarketing study to review functionality, tolerability and safety of collagen based implants (Chondrofiller gel and Chondrofiller liquid) for treatment of cartilage defects in patients with focal cartilage injuries.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This new treatment method, implanting of a collagen type I gel into the defect requiring treatment, aims at restoring the cartilage area by complete filling of the defect. This gel is either liquid when applied and solidifies within a few minutes in the treated area or it is applied directly into larger defects as gel. It is expected that in the course of time cells from the adjacent cartilage tissue and the adjoining bone migrate into the gel resulting in restoration of the cartilage area without formation of scar tissue.

The aim of this postmarketing study is to apply collagen gel into a cartilage defect of the knee, shoulder or upper ankle joint and examine the filling of the defect after 12 months by means of magnetic resonance imaging. 6 or 12 and 36 months after the surgery, the function of the knee joint and a general physical examination will be documented.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

ChondroFiller is a ready-to-use 2 component collagen matrix made of pure native collagen type I. It is intended for filling of small to medium-sized, clearly demarcated cartilage defects. The primarily liquid collagen polymerizes in the filled defect within few minutes and facilitates tailor-sized anchorage in the defect without further fixation measurements. The biological and physical nature of ChondroFiller liquid enhance incorporation of healthy chondrocytes from the adjacent healthy tissue which on their side synthesize their own collagen type II, thus allowing for conversion of ChondroFiller liquid matrix in the course of time.

This postmarketing study is performed to examine the results of filling of defects by means of collagen gel. The collagen gel is applied into a cartilage defect, either in knee, shoulder or upper ankle joint. At three timepoints after the surgery (6 or 12 months and 36 months after the surgery), functionality of the joint and general state of health are reviewed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009703
  •   2015/11/23
  •   [---]*
  •   no
  •   Approved
  •   202/14, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M94.26 -  [generalization M94.2: Chondromalacia]
  •   M19.01 -  [generalization M19.0: Primary arthrosis of other joints]
  •   M94.97 -  [generalization M94.9: Disorder of cartilage, unspecified]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   In this non-interventional study the routine treatment with the Chondrofiller in the knee, shoulder and ankle will be observed. For this, following scores will be used: (SF-36, DASH-Score [Disabilities of the Arm, Shoulder and Hand], Constant-Score, IKDC [subjective knee Evaluation form], FADI [Foot & Ankle Disability Score], FAOS [Foot and Ankle Outcome Score]).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The main endpoint is the evaluation of clinical efficacy by means of a clinical examination and determination of validated outcome scores. Following scores will be used: (DASH-Score [Disabilities of the Arm, Shoulder and Hand] and Constant-Scorefor the shoulder, IKDC [subjective knee Evaluation form] for the knee and FAOS [Foot and Ankle Outcome Score])
and FADI [Foot & Ankle Disability Score] for the ankle.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Evaluation of tolerability and safety of treatment with details on corresponding adverse events. For Evaluation of this endpoint, all unexpected events will be documented and analyzed.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/11/23
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Intact cartilage shoulder
• Intact surrounding cartilage
• Intact corresponding joint surface (damage of up to grade II according to Outerbridge is allowed)
• Intact meniscus (partial resection up to not more than 1/3 of the total volume is allowed)
• Intact ligaments, physiological mechanical axis
• Unrestricted joint flexibility
• Patients in a state of health acceptable for undergoing general anesthesia
• Defect grade III and IV according to Outerbridge
• Defect localization: knee, shoulder and upper ankle joints

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Hypersensitivity and/or allergy to collagen
• Unicompartimental arthrosis
• Multicompartimental arthrosis
• Hematopoetic disorders
• Malignant diseases
• Neurological diseases
• Increased risk of bleeding
• Pregnant or breastfeeding women
• Patients incapable of contracting or detained patients
• Joint stiffness
• Arthrofibrosis
• Infections of the joints
• Metabolic diseases
• Genu varum of >5°
• Contra-indications for MRI examinations

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Amedrix GmbH
    • Schelztorstr 54-56
    • 73728  Esslingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Amedrix GmbH
    • Mr.  Dr. rer nat.  Thomas  Graeve 
    • Schelztorstraße 54-56
    • 73728  Esslingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Amedrix GmbH
    • Mr.  Dr. rer nat.  Thomas  Graeve 
    • Schelztorstraße 54-56
    • 73728  Esslingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Amedrix GmbH
    • Schelztorstr 54-56
    • 73728  Esslingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.