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Superior cartilage repair with BST-CarGel added to conventional microfracture treatment
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December 2013
Superior cartilage repair with BST-CarGel added to conventional microfracture treatment
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:1
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):1640-50Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Eighty patients aged 18 to 55 years, with a single focal cartilage lesion on the femoral condyles and moderate knee pain, were randomized to evaluate the efficacy of BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) treatment in addition to conventional microfracture treatment and physiotherapy over 12 weeks. Patients were primarily assessed for repair tissue quantity and quality evaluated at 12 months by quantitative 3D MRI. The evidence presented in this study demonstrated that BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) treatment resulted in superior cartilage tissue, increased quantity, and improved structural characteristics when compared to microfracture treatment alone. Secondary clinical outcomes (WOMAC and SF-36) were comparable between groups, along with similar safety outcomes.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Piramal Life Sciences, Bio-Orthopaedic Division (formerly BioSyntech Canada Inc.)
Conflicts:
Company Employee
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Microfracture is the current standard of care for articular cartilage damage and although this treatment has demonstrated success, the procedure may result in poor tissue quality and highly variable outcomes due to the instability of the marrow-derived blood clots formed in the lesion. BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) was developed to stabilize the blood clot in the cartilage lesion by dispersing a soluble polymer scaffold containing chitosan (a crustacean exoskeleton glucosamine polysaccharide with desirable biomaterial properties) throughout the blood. The current evidence examining optimal interventions for articular cartilage damage suffers from low methodological quality, and this study was therefore needed to evaluate the efficacy of additional BST-CarGel in the treatment of symptomatic cartilage lesions of the femoral condyle with microfracture.
What was the principal research question?
Does BST-CarGel paired with microfracture treatment for symptomatic cartilage lesions of the femoral condyle result in superior repair cartilage quantity and quality compared to microfracture treatment alone, evaluated over 12 months?
Study Characteristics
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Population:
Eighty patients aged 18 to 55 years, with a single focal cartilage lesion on the femoral condyles and moderate knee pain (> 4cm on a 10cm visual analog scale- VAS).
Intervention:
BST-CarGel Group: Microfracture for all patients was performed arthroscopically and patients subsequently received the BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) treatment through a mini arthrotomy. The treatment was prepared and was manually mixed with fresh, autologous whole peripheral blood at a ratio of 3:1 (blood:BST-CarGel)- Mixture volume varied according to lesion size. Finally, patients underwent a 12 week physiotherapy program (maximum 32 sessions) that consisted of 6 weeks of non-weight bearing which progressed to 100% at 8 weeks and assisted passive motion manually applied during sessions (n= 41, 0 lost to follow-up; Mean Age: 35.1 +/- 9.6 years; M/F= 23/18)
Comparison:
Microfracture group: Microfracture for all patients was performed arthroscopically. The arthroscopic portals were then closed. Patients subsequently underwent a 12 week physiotherapy program (maximum 32 sessions) that consisted of 6 weeks of non-weight bearing which progressed to 100% at 8 weeks and assisted passive motion manually applied during sessions (n= 39, 2 lost to follow-up; Mean Age: 37.2 +/- 10.6 years; M/F= 25/14)
Outcomes:
Primary Outcome: repair tissue quantity (lesion % Fill) and quality (T2 relaxation time) measured by 3D quantitative MRI. Secondary Outcome: clinical benefit measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) VAS version consisting of 3 subscales: pain; stiffness; and physical function.
Tertiary Outcome: Quality of life assessed by the 36-Item Short-Form Health Survey version 2 (SF-36). All adverse events were noted.
Methods:
Multi-Centered: RCT: Single-Blinded
Time:
Patients assessed at pretreatment, and at 1, 3, 6, and 12 months.
What were the important findings?
- Baseline post-debridement lesion areas and volumes were each numerically greater for the BST-CarGel group (largest lesion: 6.77cm squared) compared to the microfracture group (largest lesion: to 4.46cm squared) (2.34 +/- 1.43 compared to 1.95 +/- 1.3cm squared; p= 0.20 and 0.95 +/- 0.82 vs. 0.70 +/- 0.53cm cubed; p= 0.12 respectively).
- At 12 months, lesions treated with BST-CarGel were filled with significantly more repair tissue (92.8% +/- 2.0%) compared to the microfracture group lesions (85.2% +/- 2.1%) (p= 0.011). BST-CarGel additionally resulted in more consistent outcomes in terms of producing a greater degree of filling.
- At 12 months, BST-CarGel treatment resulted in significantly lower (p= 0.033) adjusted T2 relaxation times (70.5 +/- 4.5ms) compared to the microfracture group (85.0 +/- 4.9ms). Note that a lower T2 relaxation time indicated an improved level of tissue quality.
- No significant differences between groups was observed for any WOMAC subscales at 12 months (all p> 0.05) and both treatments showed significant improvement from baseline in all 3 subscales (p< 0.0001).
- SF-36 scores revealed no significant differences between groups for any subscales (p> 0.05 for all), however the single-question Reported Health Transition item indicated that 75% BST-CarGel patients reported feeling “better than one year ago” compared to 60% in the microfracture group (p= 0.22).
- Reports of adverse events were similar between the BST-CarGel group (97.6%; 40 patients) compared to the microfracture group (92.3%; 36 patients). Most adverse events were of mild to moderate intensity with arthralgia being the most frequent (68.3% in the BST-CarGel group and 64.1% in the microfracture group).
- Procedure related adverse events were exhibited in 38 (92.6%) BST-CarGel group patients compared to 30 (76.2%) microfracture group patients. The BST-CarGel Group reported 5 patients (12.2%) with unanticipated device-related adverse events and 4 (9.8%) anticipated device-related adverse events that were mild to moderate in intensity. Three severe cascading unanticipated device-related adverse events occurred in a single patient.
What should I remember most?
At 12 months, BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) treatment resulted in superior cartilage tissue, increased quantity, and improved structural characteristics when compared to microfracture treatment alone. Secondary clinical outcomes were comparable between groups, along with similar safety outcomes.
How will this affect the care of my patients?
The evidence presented in this study suggested that BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division) treatment may be an effective addition to the treatment of symptomatic cartilage lesions of the femoral condyle. It is important to note that the findings of this study are limited by the relatively short follow-up period. Further study that examines long-term clinical benefit is warranted.
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