Trial record 6 of 14 for:    "Osteochondritis dissecans"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Singapore General Hospital
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01498029
First received: December 7, 2011
Last updated: March 20, 2012
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Other Articular Cartilage Disorders
Osteochondritis Dissecans
Procedure: Microfracture
Device: Cartilage Autograft Implantation System (CAIS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • MR Observations of Cartilage Repair Tissue [ Time Frame: 3 weeks post operative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Assessment of whole leg mechanical alignment [ Time Frame: 1 week prior to surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 36
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498029

Contacts
Contact: Shi-Lu Chia, PhD, MBBS +65 98171 102 chia.shi.lu@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Shi-Lu Chia, PhD, MBBS    +65 9817 1102    chia.shi.lu@sgh.com.sg   
Principal Investigator: Shi-Lu Chia, PhD, MBBS         
Sub-Investigator: Seng Jin Yeo, FRCS, MBBS         
Sub-Investigator: Zhihong Zhou, BEng         
Sub-Investigator: Andy Yew, PhD         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Shi-Lu Chia, PhD, MBBS Singapore General Hospital
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01498029     History of Changes
Other Study ID Numbers: CART/ 5 April 2011
Study First Received: December 7, 2011
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board
Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Cartilage, Articular

Additional relevant MeSH terms:
Cartilage Diseases
Osteochondritis
Osteochondritis Dissecans
Bone Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 20, 2014