Knee InjuriesNCT00314236

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

A study testing BST-CarGel with Microfracture and Microfracture without BST-CarGel in people with Knee Injuries, run by Piramal Healthcare Canada Ltd at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Knee Injuries
What is being tested?: BST-CarGel with Microfracture and Microfracture without BST-CarGel
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 18 sitesin 3 countries
Study dates: Dec 2005to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

Canada11 sites

Sports Medicine Centre - University of Calgary
Calgary, Alberta, T2N 1N4
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1
Orthopaedic and Sport Medicine Clinic of Nova Scotia
Halifax, Nova Scotia, B3H 4M2
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
New West Sports Medicine
New Westminster, British Columbia, V3L 5P5
Entralogix Clinical Group Inc.
Newmarket, Ontario, V6T 2B5
Sports Medicine Clinic - Carleton University
Ottawa, Ontario, K1S 5B6
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
Québec, Quebec, G1J 1Z4
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
Toronto, Ontario, M3N 3M5
Hospital at UBC
Vancouver, British Columbia, V6T 1Z3
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4

Other trials in Canada

Spain5 sites

Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital Begona de Gijon
Gijón, Principality of Asturias, 33204
Hospital Universitario Gregorio Maraňón
Madrid, Madrid, 28034
Hospital La Paz
Madrid, Madrid
FREMAP Centro de Prevención y Rehabilitación
Majadahonda, Madrid, 28220

Other trials in Spain

South Korea2 sites

Seoul National University Hospital
Seoul, 110-744
Kyung Hee University Medical Center
Seoul, 130-702

Other trials in South Korea

About this study

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

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.

Read the detailed description

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.

Conditions: Knee Injuries
Being tested: BST-CarGel with Microfracture, Microfracture without BST-CarGel
Keywords: Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, arthroscopy, bone marrow stimulation, Chondrogenesis, Scaffold, Chitosan, A02.165.165, A10.165.382.332, G07.574.500.325.377.625.180, A10.165.382.400, Articular Cartilage Repair
Medical subject headings: Knee Injuries, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BST-CarGel with MicrofractureDevice
Microfracture performed with BST-CarGel added to the treated defect
Microfracture without BST-CarGelProcedure or surgery
Microfracture performed without BST-CarGel added to the treated defect.

Study groups in NCT00314236
Study group	Role	What they receive
Microfracture with BST-CarGel	Experimental	BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle Receives: Device: BST-CarGel with Microfracture
Microfracture without BST-CarGel	Active comparator	Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle Receives: Procedure: Microfracture without BST-CarGel

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
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.
Measured: 12 months
Repair Cartilage T2 Relaxation Time
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).
Measured: 12 months

Secondary outcomes (2)

Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
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.
Measured: 12 months
Frequency of Adverse Events Between Study Groups
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005May 2011

First posted13 Apr 2006 (estimated)
Study startDec 2005
Primary completionFeb 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Knee InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00314236
Sponsor's protocol ID: CG-CIP01-P
Status last verified: Dec 2015
First submitted: 11 Apr 2006
Last updated: 18 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-2686. doi: 10.2106/JBJS.D.02536.
PubMed 16322617
Chevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26.
PubMed 17008111
Hoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8.
PubMed 16895758
Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
PubMed 24048551

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Knee Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle
ClinicalTrials.gov ID: NCT00314236
Acronym / sponsor ID: CG-CIP01-P
Conditions: Knee Injuries
Keywords: Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, arthroscopy, bone marrow stimulation, Chondrogenesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Piramal Healthcare Canada LtdIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Feb 2011 (actual)
Study completion: May 2011 (actual)
First posted: 13 Apr 2006 (estimated)
Results: Posted 18 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Microfracture with BST-CarGel	Experimental	Device: BST-CarGel with MicrofractureBST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Microfracture without BST-CarGel	Active comparator	Procedure: Microfracture without BST-CarGelMicrofractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BST-CarGel with MicrofractureMicrofracture performed with BST-CarGel added to the treated defect	Device	Microfracture with BST-CarGel
Microfracture without BST-CarGelMicrofracture performed without BST-CarGel added to the treated defect.	Procedure or surgery	Microfracture without BST-CarGel

Primary outcome

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.
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).

2 secondary outcomes

Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Time frame: 12 months
Frequency of Adverse Events Between Study Groups
Time frame: 12 months

Results and safety

Results posted to the registry on 18 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	41	41
Control	39	37

Primary outcome: Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.

Time frame: 12 months. Least squares mean (Standard Error). Unit: Percentage of lesion fill

Measure	Experimental n = 41	Control n = 37
Value	92.81 (1.98)	85.22 (2.08)

Experimental vs Control: p = 0.011, ANCOVA

Population analysed: Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)

Primary outcome: Repair Cartilage T2 Relaxation Time

Time frame: 12 months. Least squares mean (Standard Error). Unit: milliseconds

Measure	Experimental n = 41	Control n = 37
Value	70.46 (4.49)	85.04 (4.89)

Experimental vs Control: p = 0.033, ANCOVA

Population analysed: Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	5 of 41 (12.2%)	40 of 41 (97.6%)	Not reported
Control	1 of 39 (2.6%)	36 of 39 (92.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16322617Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-2686. doi: 10.2106/JBJS.D.02536.
Background: PubMed 17008111Chevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26.
Background: PubMed 16895758Hoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8.
Results publication: PubMed 24048551Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Stanish, MD principal investigator

Orthopaedic and Sport Medicine - Dalhousie University

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BST-CarGel with Microfracture and Microfracture without BST-CarGel in people with Knee Injuries, run by Piramal Healthcare Canada Ltd at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada, Spain, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00314236, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.