A randomized clinical trial comparing the effectiveness of rotator cuff repair with or without augmentation with porcine small intestine submucosa (SIS) for large rotator cuff tears: Pilot study phase
| ISRCTN | ISRCTN73698035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73698035 |
| Secondary identifying numbers | MCT-63140 |
- Submission date
- 05/09/2005
- Registration date
- 05/09/2005
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gordon Henry Guyatt
Scientific
Scientific
Clinical Epidemiology & Biostatistics
HSC-2C12
McMaster University
1200 Main Street West
Hamilton
L8N 3Z5
Canada
| Phone | +1 905 525 9140 (22900) |
|---|---|
| guyatt@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomized clinical trial comparing the effectiveness of rotator cuff repair with or without augmentation with porcine small intestine submucosa (SIS) for large rotator cuff tears: Pilot study phase |
| Study acronym | RESTORE |
| Study objectives | 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(s) | Ethics approval received from the McMaster University Research Ethics Board on the 20th June 2003. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2003 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 62 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Clinical Epidemiology & Biostatistics
Hamilton
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Office of the Associate Dean
Research
McMaster University
Faculty of Health Sciences
1200 Main Street West
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
| Website | http://www.mcmaster.ca/ |
|---|---|
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63140)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2016 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: Publication reference and total final enrolment number added.
