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Trial record 17 of 23 for:    Osteochondritis Dissecans

Knee Articular Cartilage Repair: Cartilage Autograft Implantation System Versus Conventional Microfracture (CAIS)

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ClinicalTrials.gov Identifier: NCT01498029
Recruitment Status : Unknown
Verified December 2011 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : December 23, 2011
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Tracking Information
First Submitted Date  ICMJE December 7, 2011
First Posted Date  ICMJE December 23, 2011
Last Update Posted Date March 21, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 3 weeks post operative ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 6 months post-operative ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 1 year post-operative ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 1 week prior to surgery ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 3 months post-operative ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 1 year post-operative ]
    The MOCART (MR Observations of Cartilage Repair Tissue) scoring system, which has been well validated in studies of cartilage regeneration techniques, will be used to assess the cartilage repair response
Change History Complete list of historical versions of study NCT01498029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
  • Assessment of whole leg mechanical alignment [ Time Frame: 1 week prior to surgery ]
    Standard weight-bearing plain radiographs of the knee, as well as long leg standing films to assess mechanical alignment, will also be performed.
  • Assessment of whole leg mechanical alignment [ Time Frame: 1 month post-operative ]
    Standard weight-bearing plain radiographs of the knee, as well as long leg standing films to assess mechanical alignment, will also be performed.
  • Assessment of whole leg mechanical alignment [ Time Frame: 3 month post-operative ]
    Standard weight-bearing plain radiographs of the knee, as well as long leg standing films to assess mechanical alignment, will also be performed.
  • Assessment of whole leg mechanical alignment [ Time Frame: 6 month post-operative ]
    Standard weight-bearing plain radiographs of the knee, as well as long leg standing films to assess mechanical alignment, will also be performed.
  • Assessment of whole leg mechanical alignment [ Time Frame: 1 year post-operative ]
    Standard weight-bearing plain radiographs of the knee, as well as long leg standing films to assess mechanical alignment, will also be performed.
  • Clinical and functional evaluation using standardised and validated scoring system [ Time Frame: 1 week prior to surgery ]
    Pre- and post-operative assessment (1,3,6 and 12 months) of the diseased knee will be performed using standardised, validated scoring systems: SF-36 (general health), KOOS and ICRS (disease-specific) scores
  • Clinical and functional evaluation using standardised and validated scoring system [ Time Frame: 1 month post-operative ]
    Pre- and post-operative assessment (1,3,6 and 12 months) of the diseased knee will be performed using standardised, validated scoring systems: SF-36 (general health), KOOS and ICRS (disease-specific) scores
  • Clinical and functional evaluation using standardised and validated scoring system [ Time Frame: 3 month post-operative ]
    Pre- and post-operative assessment (1,3,6 and 12 months) of the diseased knee will be performed using standardised, validated scoring systems: SF-36 (general health), KOOS and ICRS (disease-specific) scores
  • Clinical and functional evaluation using standardised and validated scoring system [ Time Frame: 6 month post-operative ]
    Pre- and post-operative assessment (1,3,6 and 12 months) of the diseased knee will be performed using standardised, validated scoring systems: SF-36 (general health), KOOS and ICRS (disease-specific) scores
  • Clinical and functional evaluation using standardised and validated scoring system [ Time Frame: 1 year post-operative ]
    Pre- and post-operative assessment (1,3,6 and 12 months) of the diseased knee will be performed using standardised, validated scoring systems: SF-36 (general health), KOOS and ICRS (disease-specific) scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Knee Articular Cartilage Repair: Cartilage Autograft Implantation System Versus Conventional Microfracture
Official Title  ICMJE A Randomised Clinical Trial Comparing a Novel Single-stage Autologous Cartilage Implantation System to Conventional Microfracture for Repair of Articular Cartilage Defects in the Knee
Brief Summary

The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which cartilage is harvested from non-critical regions of articular cartilage, but then immediately morcellated and loaded onto a polymer membrane-scaffold, which is subsequently used to fill the chondral defect. The autograft-membrane composite is fixed to the defect with a biodegradable staple.

The investigators aim to evaluate this new technique through a pilot clinical trial involving 36 patients randomized into microfracture and CAIS treatment arms (randomisation ratio 1:2), with a minimum follow-up of 1 year, using both clinical and radiological (magnetic resonance imaging) outcomes. If the results of this pilot trial are successful, the investigators plan to expand the study by recruiting more patients to achieve a suitably-powered trial.

Primary hypothesis 1: That functional scores will increase by at least 0.5 SD over pre-operative values, by 1 year following the CAIS procedure

Primary hypothesis 2: That articular cartilage height will have a sustained increase of at least 2 mm at 1 year following the CAIS procedure

Primary hypothesis 3: That functional scores in the CAIS group will be equivalent or superior to those in the microfracture group

Detailed Description

Articular cartilage has limited potential for regeneration, and full-thickness cartilage defects in the knee are frequently symptomatic and debilitating. If left untreated, such injuries may progress to generalized osteoarthritis. The management of these injuries remains unsatisfactory despite intense research activity, and the clinical and social impact of this problem is growing, involving as it often does the young and the active.

Numerous surgical techniques have been developed to treat these injuries, but none has yet been shown to be superior. One of the most widely employed and best-studied means of achieving cartilage repair in patients with discrete regions of chondral destruction in the knee is that of microfracture. Microfracture is an arthroscopic technique that involves penetrating the subchondral bone at the base of full-thickness articular cartilage defects, thus allowing marrow pluripotent stem cells to egress into the chondral defect, facilitating cartilage repair. However, doubts have been raised concerning the quality and durability of the microfracture-induced repair tissue. In recent years, autologous chondrocyte implantation (ACI) has emerged as the technique with the greatest potential for advancing the management of chondral injury. In this procedure, autologous chondrocytes are harvested from non-critical areas on the articular surface, then expanded through cell culture in the laboratory, before being implanted 4-6 weeks later into the chondral defect, using a 'patch' of adjacent periosteum for containment of the cells within the defect. There are several disadvantages to the ACI technique just described: it is a two-stage procedure, chondrocyte culture can be lengthy and expensive, and the periosteal patch used to contain the cells is associated with a significant risk of complications such as detachment and hypertrophy. 2nd generation ACI techniques have focused on addressing some of these problems by substituting the periosteum patch with artificial membranes that served as scaffolds for the cultured chondrocytes.

A novel technique has recently been developed that could prove to avoid some of the deficiencies of the ACI technique. The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which cartilage is harvested from non-critical regions of articular cartilage, but then immediately morcellated and loaded onto a polymer membrane-scaffold, which is subsequently used to fill the chondral defect. The autograft-membrane composite is fixed to the defect with a biodegradable staple.

We aim to evaluate this new technique through a pilot clinical trial involving 36 patients randomized into microfracture and CAIS treatment arms (randomisation ratio 1:2), with a minimum follow-up of 1 year, using both clinical and radiological (magnetic resonance imaging) outcomes. If the results of this pilot trial are successful, we plan to expand the study by recruiting more patients to achieve a suitably-powered trial.

Primary hypothesis 1: That functional scores will increase by at least 0.5 SD over pre-operative values, by 1 year following the CAIS procedure

Primary hypothesis 2: That articular cartilage height will have a sustained increase of at least 2 mm at 1 year following the CAIS procedure

Primary hypothesis 3: That functional scores in the CAIS group will be equivalent or superior to those in the microfracture group

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Other Articular Cartilage Disorders
  • Osteochondritis Dissecans
Intervention  ICMJE
  • Procedure: Microfracture
    The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue
    Other Names:
    • Knee
    • Cartilage
    • Cartilage Repair
  • Device: Cartilage Autograft Implantation System (CAIS)
    The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
    Other Names:
    • Knee
    • Cartilage
    • Cartilage Repair
Study Arms  ICMJE
  • Active Comparator: Randomized to Microfracture
    This group of patients who have been randomised to receive microfracture procedure will be the control group for this study
    Intervention: Procedure: Microfracture
  • Experimental: Randomized to CAIS
    This group of patients who have been randomised to receive the CAIS procedure will be the experimental group for this study
    Intervention: Device: Cartilage Autograft Implantation System (CAIS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Full-thickness articular cartilage defect on the femoral condyle or trochlea greater than 2 cm2 but less than 10 cm2 in total surface area, following debridement to healthy, stable tissue.
  • Knee mechanical axis malalignment of not more than 3 degrees either varus or valgus from neutral.
  • Patient is fit for surgery.

Exclusion Criteria:

  • Multifocal disease
  • Tibial plateau lesions
  • Patella lesions
  • Absent menisci or meniscal tears that are unstable and cannot be successfully debrided
  • Non-intact cruciate and collateral ligaments
  • Inflammatory or crystalline arthropathy
  • Systemic medication or conditions likely to compromise chondrocyte cell proliferation and differentiation, e.g. Cushing's syndrome, chemotherapy
  • Morbid obesity (more than 150% ideal body weight)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498029
Other Study ID Numbers  ICMJE CART/ 5 April 2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shi-Lu Chia, PhD, MBBS Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP