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NCT Number: NCT00314236

Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee

This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.

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Key information

Conditions

Knee Injuries Fractures, Bone Fractures, Stress Leg Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine Centre - University of Calgary, Calgary, Alberta, Canada

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About this study

Cartilage repair currently remains a problematic orthopedic concern with no effective solution. The development of new surgical techniques or therapies is critical in meeting this medical need.

This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. The subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. However, although the treatment will not be blinded, the primary effectiveness assessment will be blinded. The primary endpoint of this study will be cartilage repair at 12 months proved by demonstrating that BST-CarGel treatment effectively fills cartilage lesions with high quality cartilaginous tissue. The secondary endpoints will be pain, stiffness and function while other tertiary endpoints will include safety, quality-of-life (QOL), as well as macroscopic characterizations of tissue repair. The primary measure of this study will occur at 12 months, when imaging of repair tissue using magnetic resonance (MR) and associated analyses will compare tissue volume, quality and other anatomical variables. Radiographic evaluations will be blinded. Volunteer biopsies at 13 months may be obtained. Pain, stiffness, function and QOL will be assessed prior to treatment, and at 3, 6 and 12 months following treatment using self-administered validated scores (WOMAC and SF-36). In addition, subject safety will be assessed through a record of adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 55 years of age
  • Focal articular cartilage lesion on the medial femoral condyle
  • Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
  • Stable knee

Exclusion criteria

  • Multiple lesions or kissing lesions
  • Clinically relevant compartment malalignment (> 5 degrees)
  • Undergone ligament treatments in the affected knee within 2 years prior to trial
  • Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
  • Previous surgical cartilage treatments in the affected knee in the last 12 months

Treatment and study plan

BST-CarGel with Microfracture

Device

Microfracture performed with BST-CarGel added to the treated defect

Microfracture without BST-CarGel

Procedure

Microfracture performed without BST-CarGel added to the treated defect.

Primary outcomes

  1. Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.

    Time frame: 12 months

    Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.

  2. Repair Cartilage T2 Relaxation Time

    Time frame: 12 months

    Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).

Secondary outcomes

  1. Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)

    Time frame: 12 months

    The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.

  2. Frequency of Adverse Events Between Study Groups

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Piramal Healthcare Canada Ltd

Industry

Registry information

Official study title

A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2006
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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