Contact information
Type
Scientific
Primary contact
Dr Gordon Henry Guyatt
ORCID ID
Contact details
Clinical Epidemiology & Biostatistics
HSC-2C12
McMaster University
1200 Main Street West
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 (22900)
guyatt@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-63140
Study information
Scientific title
Acronym
RESTORE
Study hypothesis
To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patients with large rotator cuff tears.
Ethics approval
Ethics approval received from the McMaster University Research Ethics Board on the 20th June 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rotator cuff tears
Intervention
1. Standard open rotator cuff repair
2. Standard open rotator cuff repair augmented with porcine small intestine submucosa (RESTORE patch)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Success or failure of the rotator cuff repair. Patients will undergo Magnetic Resonance Imaging (MRI) of the rotator cuff one year post-operatively to determine whether the defect has healed, and if not healed completely, whether the remaining full thickness defect is greater than 5 mm in any dimension. If such a defect remains, the patient is classified as having failed the repair.
Secondary outcome measures
1. The Western Ontario Rotator Cuff Index (WORC)
2. The American Shoulder and Elbow Surgeons standardized tool (ASES)
3. The Simple Shoulder Test (SST)
4. The Constant
5. The SF-36
Overall trial start date
01/09/2003
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (18 - 65 years old, either sex) with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al. (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B = full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy
2. Inability of the surgeon to repair the tear with remaining defect no greater than 5 mm in diameter
3. Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion
4. Active joint or systemic infection
5. Significant muscle paralysis of the shoulder girdle
6. Migration of the humeral head as demonstrated on plain radiograph
7. Major medical illness that would preclude undergoing surgery
8. Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
9. Major psychiatric illness, developmental handicap or inability to read and understand the English language
Recruitment start date
01/09/2003
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Canada
Trial participating centre
Clinical Epidemiology & Biostatistics
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Office of the Associate Dean
Research
McMaster University
Faculty of Health Sciences
1200 Main Street West
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63140)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list