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    Clinical Trial Results:
    PHASE III PROTOCOL COMPARING A MICROFRACTURE TREATMENT TO A CARTIPATCH® CHONDROCYTE GRAFT TREATMENT IN FEMORAL CONDYLE LESIONS

    Summary
    EudraCT number
    		 2007-003481-18
    Trial protocol
    		 BE  
    Global end of trial date
    31 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2021
    First version publication date
    22 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CART.III.
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TBF Genie Tissulaire
    Sponsor organisation address
    6 rue d'Italie, Mions, France, 69780
    Public contact
    Laurence BARNOUIN, TBF Genie Tissulaire, +33 (0)4 72 68 69 09, laurence.barnouin@tbf-lab.com
    Scientific contact
    Laurence BARNOUIN, TBF Genie Tissulaire, +33 (0)4 72 68 69 09, laurence.barnouin@tbf-lab.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the Cartipatch® chondrocyte graft-treated groups
    Protection of trial subjects
    Every cartilage biopsy received was checked to verify their compliance before CARTIPATCH® implantation. Investigators were informed if, for unexpected reasons, the chondrocyte expansion through cell culture could not be initiated. Possible reasons can be either initial poor quality of collected cartilage, or failure during CARTIPATCH® manufacturing. Any adverse event related to cell culture was discussed with the main surgeon and the surgeons in relation with the patient to find a satisfactory solution (performing of a second procurement for instance).
    Background therapy
    		 -
    Evidence for comparator
    		 Comparison of CARTIPATCH® to reference therapy (microfracture treatment).
    Actual start date of recruitment
    11 Nov 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    Norway: 8
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Israel: 10
    Worldwide total number of subjects
    32
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 64 patients were expected to be included in the study and to be distributed in two groups of equal size (32 patients per group). As the overall trial enrolment could not be reached in time, inclusion period was delayed several times and study was then early terminated. Finally, a total of 32 patients were included in 6 centers.

    Pre-assignment
    Screening details
    		 Forty-six patients were recorded in the study. On this 46 recorded patients, 32 patients were included.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Reference arm : microfracture treatment
    Arm type
    		 Reference treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Arm B
    Arm description
    		 Experimental arm, CARTIPATCH®
    Arm type
    		 Experimental

    Investigational medicinal product name
    CARTIPATCH®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Dosage : not applicable Surgical treatment : - 1st operative step: Arthroscopy to collect cartilage - 2nd operative step: Implantation by arthrotomy about 6 weeks following arthroscopy

    Number of subjects in period 1
    		Arm A Arm B
    Started
    18
    14
    Completed
    12
    9
    Not completed
    6
    5
         Graft washed out 1.5 months post-surgery
    -
    1
         Lost to follow-up
    2
    -
         Missing data
    1
    2
         Not treated
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Reference arm : microfracture treatment

    Reporting group title
    Arm B
    Reporting group description
    		 Experimental arm, CARTIPATCH®

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 18 14 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 18 14 32
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 33 (20 to 45) 34 (19 to 46) -
    Gender categorical
    Units: Subjects
        Female
    		 8 3 11
        Male
    		 10 11 21
    Lesion size
    Units: cm2
        arithmetic mean (full range (min-max))
    		 3.46 (2.52 to 5.76) 4.08 (2.50 to 6.25) -
    Subject analysis sets

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Analysis was done by study arm. All treated patients followed up to 18 months post-surgery were included in the analysis.

    Subject analysis sets values
    		 Treated patients
    Number of subjects
    21
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    21
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male
    Lesion size
    Units: cm2
        arithmetic mean (full range (min-max))

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Reference arm : microfracture treatment

    Reporting group title
    Arm B
    Reporting group description
    		 Experimental arm, CARTIPATCH®

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Analysis was done by study arm. All treated patients followed up to 18 months post-surgery were included in the analysis.

    Primary: Patient part of IKDC subjective score

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    End point title
    		 Patient part of IKDC subjective score
    End point description
    End point type
    Primary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: scale from 0 to 100
        arithmetic mean (full range (min-max))
    66 (34 to 86)
    59 (32 to 98)
    63 (32 to 98)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    Statistical analysis to assess difference between treatments was not performed.
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Not assessed
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Primary: Surgeon part of IKDC score

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    End point title
    		 Surgeon part of IKDC score
    End point description
    End point type
    Primary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: Grade
        Grade A
    7
    6
    13
        Grade B
    4
    0
    4
        Grade C
    0
    2
    2
        Grade D
    0
    1
    1
    Statistical analysis title
    		 Surgeon part of IKDC score
    Statistical analysis description
    Statistical analysis to assess difference between treatments was not performed.
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Not assessed
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Secondary: KOOS clinical scores: SYMPTOMS

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    End point title
    		 KOOS clinical scores: SYMPTOMS
    End point description
    End point type
    Secondary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: 0-100
        arithmetic mean (full range (min-max))
    81.6 (53.6 to 92.9)
    71.8 (42.9 to 100)
    77.4 (42.9 to 100)
    No statistical analyses for this end point

    Secondary: KOOS clinical scores: PAIN

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    End point title
    		 KOOS clinical scores: PAIN
    End point description
    End point type
    Secondary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: 0-100
        arithmetic mean (full range (min-max))
    78.9 (50.0 to 97.2)
    73.5 (47.2 to 100)
    76.6 (47.2 to 100)
    No statistical analyses for this end point

    Secondary: KOOS clinical scores: ACTIVITY OF DAILY LIVING

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    End point title
    		 KOOS clinical scores: ACTIVITY OF DAILY LIVING
    End point description
    End point type
    Secondary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: 0-100
        arithmetic mean (full range (min-max))
    84.6 (63.2 to 100)
    77.1 (39.7 to 100)
    81.3 (39.7 to 100)
    No statistical analyses for this end point

    Secondary: KOOS Clinical scores: SPORTS & RECREATIONAL ACTIVITIES

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    End point title
    		 KOOS Clinical scores: SPORTS & RECREATIONAL ACTIVITIES
    End point description
    End point type
    Secondary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: 0-100
        arithmetic mean (full range (min-max))
    56 (0 to 90)
    42 (0 to 100)
    50 (0 to 100)
    No statistical analyses for this end point

    Secondary: KOOS clinical scores: QUALITY OF LIFE

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    End point title
    		 KOOS clinical scores: QUALITY OF LIFE
    End point description
    End point type
    Secondary
    End point timeframe
    18 months post-surgery
    End point values
    		 Arm A Arm B Treated patients
    Number of subjects analysed
    12
    9
    21
    Units: 0-100
        arithmetic mean (full range (min-max))
    45.8 (12.5 to 87.5)
    52.1 (6.3 to 100)
    48.5 (6.3 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events had to be reported during the whole study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Arm A (microfracture)
    Reporting group description
    		 No adverse events declared in microfracture group.

    Reporting group title
    Arm B (CARTIPATCH®)
    Reporting group description
    		 9 adverse events were declared in CARTIPATCH® group affecting 5 patients. 7 of them were probably related to the treatment, 2 were not. 4 of the adverse events were serious adverse events. Serious adverse events: - Septic arthritis - Knee contracture probably due to rehabilitation protocol and chondral defect of medial condyle - Infection of surgical scar, suspected septic arthritis Adverse events: - Fracture of contralateral ankle - Pain, high blood pressure (not related to CARTIPATCH® graft), tachycardia (not related to CARTIPATCH® graft) - Knee stiffness in range from 90° to full flexion due to adhesions

    Serious adverse events
    		 Arm A (microfracture) Arm B (CARTIPATCH®)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 14 (21.43%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Chondral defect
    Additional description: Chondral defect of medial condyle
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Knee contracture
    Additional description: Knee contracture probably due to rehabilitation protocol
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic arthritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site infection
    Additional description: Infection of surgical scar with suspected septic arthritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A (microfracture) Arm B (CARTIPATCH®)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 14 (21.43%)
    Injury, poisoning and procedural complications
    Fracture of ankle
    Additional description: Fracture of contralateral ankle
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Cardiac disorders
    High blood pressure
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Knee stiffness
    Additional description: Knee stiffness in range from 90° to full flexion due to adhesions
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated prematurely because of difficulties in recruiting patients. The decision did not involve any safety reason. As the statistical analysis of the collected data was not performed, it is impossible to conclude on the product.
    For support, Contact us.
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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