Condition category
Musculoskeletal Diseases
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
11/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mcmaster.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes