Knee InjuriesNCT01246895
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
An observational study of Knee Injuries, run by Piramal Healthcare Canada Ltd at 16 sites in 2 countries.
Trial summary
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Microfracture with BST-CarGel and Microfracture without BST-CarGel
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Mar 2011to Mar 2014
- Phase
- Observational
- 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
Study population: Patients that have been treated under either protocol CG-CIP01 or CG-CIP02
Who may be able to join
- The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period
- The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)
Who cannot join
- The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
- The subject did not complete 12 month follow-up period
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Canada11 sites
University of Calgary Sports Medicine Centre
Calgary, Alberta, T2N 1N4
Orthopaedic and Sport Medicine Clinic of Nova Scotia
Halifax, Nova Scotia, B3H 4M2
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Simon Fraser Orthopaedic Fund, Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6J 3L7
Sports Medicine Center, Carleton University
Ottawa, Ontario, K1S 5B6
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4
Hôpital Charles LeMoyne, Unité d'investigation non invasive
Québec, Quebec, J4V 2H1
Sunnybrook Health Sciences Centre, Orthopaedics Research Office
Toronto, Ontario, M4N 3M5
Joint Preservation Centre of British Columbia
Vancouver, British Columbia, V6T 2B5
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
Spain5 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Cirugia Ortopedica y Traumatologia, Medicina del Deporte
Gijón
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario La Paz
Madrid
FREMAP Centro de Prevención y Rehabilitatión
Majadahonda, Madrid
About this study
Official title: Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.
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.
Clinical data regarding the long-term durability of repair tissue resulting from cartilage repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term repair outcomes (over 4 years). These studies reinforced the concept that further studies are needed to identify a technique or product that will lead to long-term clinical benefit through improved cartilage repair efficacy.
BST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and has been shown to promote the quantity and quality of cartilage repair tissue in animals. The efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the standard of care treatment, microfracture, in a 12 month international study in Canada, Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc. Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the owner of the technology and the sponsor for this Extension Study CG-C1P04.
This follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® + microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.
All eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P and completed the required 12 month follow-up period will be asked to participate in this follow-up study.
The stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion type) will be retained for the purposes of the follow-up study, and all third parties such as the MRI central reading facility will remain blinded to the treatment received under Protocols CG-CIP01-P and CG-CIP02-P.
Comparisons between the two treatment groups will be performed.
The following assessments will be done annually at years 3 and/or 4 and 5 post -treatment under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture or microfracture alone:
- Analyses of tissue repair will be carried out based on the degree of lesion filling and quality of repair tissue using MRI
- The general health status of subjects will be captured in the case report form (CRF) and will include the subject's overall health status, treated knee status, adverse events (AEs) and concomitant medications.
- The assessment of the subject's knee pain, stiffness, functional ability and quality of life through self-assessment questionnaires (Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)
- Conditions
- Knee Injuries
- Being tested
- Microfracture with BST-CarGel, Microfracture without BST-CarGel
- Keywords
- Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, Arthroscopy, Bone Marrow Stimulation, Chondrogenesis, Scaffold, Chitosan, 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.
Microfracture with BST-CarGelDevice
Microfracture without BST-CarGelDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Microfracture with BST-CarGel Receives: Device: Microfracture with BST-CarGel | |
| Control | Microfracture without BST-CarGel Receives: Device: Microfracture without BST-CarGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.
Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).
Measured: 5 years
Repair Tissue Quality (T2 MRI)
Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.
Measured: 5 years
Secondary outcomes (2)
Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (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. A higher score indicates a better health state improvement.
Measured: 5 years
The Number of Participants With Adverse Events Until 5 Years
Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionFeb 2014
- Study completionMar 2014
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 (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Healthcare Canada Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Stanish, M.D, Principal investigator, Orthopaedic and Sport Medicine - Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246895
- Sponsor's protocol ID
- CG-CIP04-P
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2010
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Not planned
Publications
Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.
PubMed 26069709
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)
- ClinicalTrials.gov ID
- NCT01246895
- Acronym / sponsor ID
- CG-CIP04-P
- Conditions
- Knee Injuries
- Keywords
- Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, Arthroscopy, Bone Marrow Stimulation, Chondrogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Piramal Healthcare Canada LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Posted 24 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.
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.
Clinical data regarding the long-term durability of repair tissue resulting from cartilage repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term repair outcomes (over 4 years). These studies reinforced the concept that further studies are needed to identify a technique or product that will lead to long-term clinical benefit through improved cartilage repair efficacy.
BST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and has been shown to promote the quantity and quality of cartilage repair tissue in animals. The efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the standard of care treatment, microfracture, in a 12 month international study in Canada, Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc. Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the owner of the technology and the sponsor for this Extension Study CG-C1P04.
This follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® + microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.
All eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P and completed the required 12 month follow-up period will be asked to participate in this follow-up study.
The stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion type) will be retained for the purposes of the follow-up study, and all third parties such as the MRI central reading facility will remain blinded to the treatment received under Protocols CG-CIP01-P and CG-CIP02-P.
Comparisons between the two treatment groups will be performed.
The following assessments will be done annually at years 3 and/or 4 and 5 post -treatment under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture or microfracture alone:
- Analyses of tissue repair will be carried out based on the degree of lesion filling and quality of repair tissue using MRI
- The general health status of subjects will be captured in the case report form (CRF) and will include the subject's overall health status, treated knee status, adverse events (AEs) and concomitant medications.
- The assessment of the subject's knee pain, stiffness, functional ability and quality of life through self-assessment questionnaires (Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Device: Microfracture with BST-CarGelMicrofracture with BST-CarGel |
| Control | – | Device: Microfracture without BST-CarGelMicrofracture without BST-CarGel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients that have been treated under either protocol CG-CIP01 or CG-CIP02
Key inclusion criteria (2 listed)
- The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period
- The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)
Key exclusion criteria (2 listed)
- The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
- The subject did not complete 12 month follow-up period
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 |
|---|---|---|
| Microfracture with BST-CarGel | Device | Experimental |
| Microfracture without BST-CarGel | Device | Control |
Primary outcome
Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.
Time frame: 5 years
Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).
Repair Tissue Quality (T2 MRI)
Time frame: 5 years
Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.
2 secondary outcomes
Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)
Time frame: 5 years
The Number of Participants With Adverse Events Until 5 Years
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26069709Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.
- Individual participant dataSharing planned: No. Not planned
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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, M.D principal investigator
Orthopaedic and Sport Medicine - Dalhousie University
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by Piramal Healthcare Canada Ltd at 16 sites in 2 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 2 inclusion and 2 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, Spain. 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 24 Jan 2018). 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 Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI. (time frame: 5 years). 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 NCT01246895, which also lists 1 linked publication.
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 24 Jan 2018.