Bioinductive Implant, Rotator Cuff Tears
Conditions
Keywords
shoulder, rotator cuff, clinical outcomes, radiographic outcomes, biomechanics, bridging reconstruction, rotator cuff repair
Brief summary
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
Interventions
PROCEDUREBridging Reconstruction using BioBrace
Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.
PROCEDURERepair
Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.
Sponsors
CONMED Corporation
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware to the type of surgery that they received. The investigator will not be blinded, however, the individuals assessing the outcomes will be.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff * over 18 years of age
Exclusion criteria
* glenohumeral osteoarthritis * Western Ontario rotator cuff score \>60 * uncontrolled diabetes (Hgb A1C \>7%) * pregnant * local or systemic infection * inability to cooperate with and/or comprehend post-operative instructions * MRI proven non-vascular sites * poor nutritional state (Alb \<30 g/L) * cancer * paralysis of the shoulder * contracture of the shoulder * patients unable to provide informed consent for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic or clinical failure | 2 years | The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Atrophy | 2 year | Using MRI, muscle atrophy will be measured using Warner's classification between groups. |
| Fatty Infiltration | 2 year | Fatty infiltration using the Goutallier classification will be used and identified |
| Healing Rate | 2 year | To measure the structural integrity of the surgery, Sugaya method will be used. |
| Western Ontario Rotator Cuff Index (WORC) | Baseline, 6-month, 1-year, 2-years | WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years |
| Acromiohumeral Distance | 2 year | Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays. |
| EQ-5D-5L | Baseline, 6-month, 1-year, 2-years | EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years |
| Range of motion | Baseline, 6-month, 1-year, 2-years | The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years |
| Shoulder strength | Baseline, 6-month, 1-year, 2-years | The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years |
| Biomechanics and Muscle Activity | Baseline and 2 years | Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment. |
| American Shoulder and Elbow Surgeon survey | Baseline, 6-month, 1-year, 2-years | American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years |
Countries
Canada
Contacts
Primary ContactSarah Remedios, MSc
Outcome results
None listed