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
Protocol serial number	MCT-63140
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Clinical Epidemiology & Biostatistics
HSC-2C12
McMaster University
1200 Main Street West
Hamilton
L8N 3Z5
Canada

Phone	+1 905 525 9140 (22900)
Email	guyatt@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.