Knee Articular Cartilage Repair: Cartilage Autograft Implantation System Versus Conventional Microfracture

NCT01498029 | Unknown Phase 3

• 1 other identifier: CART/ 5 April 2011
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Other Articular Cartilage Disorders; Osteochondritis Dissecans

Keywords

Cartilage, Articular

Outcome Measures

Primary Outcomes (3)

• MR Observations of Cartilage Repair Tissue

  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

  3 weeks post operative

• MR Observations of Cartilage Repair Tissue

  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

  6 months post-operative

• MR Observations of Cartilage Repair Tissue

  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

  1 year post-operative

Secondary Outcomes (10)

• Assessment of whole leg mechanical alignment

  1 week prior to surgery

• Assessment of whole leg mechanical alignment

  1 month post-operative

• Assessment of whole leg mechanical alignment

  3 month post-operative

• Assessment of whole leg mechanical alignment

  6 month post-operative

• Assessment of whole leg mechanical alignment

  1 year post-operative

Study Arms (2)

Randomized to Microfracture

ACTIVE COMPARATOR

This group of patients who have been randomised to receive microfracture procedure will be the control group for this study

Procedure: Microfracture

Randomized to CAIS

EXPERIMENTAL

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)

Interventions

Microfracture PROCEDURE

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

Also known as: Knee, Cartilage, Cartilage Repair

Randomized to Microfracture

Cartilage Autograft Implantation System (CAIS) DEVICE

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.

Also known as: Knee, Cartilage, Cartilage Repair

Randomized to CAIS

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Osteochondritis Dissecans

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Shi-Lu Chia, PhD, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi-Lu Chia, PhD, MBBS

CONTACT

+65 98171 102; chia.shi.lu@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 21, 2012

Record last verified: 2011-12

Locations

SG (1)