Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001082998
Ethics application status
Approved
Date submitted
15/10/2011
Date registered
19/10/2011
Date last updated
1/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Scaffold Implant for Rotator Cuff Lesions Encountered on the Supraspinatus Tendon
Scientific title
Study to determine if the addition of a collagen scaffold device will increase tendon thickness with comparable clinical outcomes over subacromial decompression and/or repair alone in patients with a supraspinatus tear.
Secondary ID [1] 273218 0
Nil
Universal Trial Number (UTN)
U1111-1123-0595
Trial acronym
Circles Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supraspinatus tendon tears 278981 0
Condition category
Condition code
Musculoskeletal 279157 279157 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 – Partial thickness tears surgically treated with the addition of an implanted collagen scaffold
Arm 2 – Partial thickness tears surgically treated without the addition of an implanted collagen scaffold; standard subacromial decompression and/or repair alone (control)
Arm 3 – Larger partial thickness tears or small full thickness tears surgically treated with the addition of an implanted collagen scaffold

The surgical placement of the collagen scaffold following standard decompression and/or repair in treatment Arms 1 and 3 is expected to add approximately 20 minutes to the standard rotator cuff tear procedure in Arm 2 (control), which takes approximately 40 to 90 minutes depending on the size and complexity of the tear.
Intervention code [1] 269548 0
Treatment: Devices
Comparator / control treatment
Arm 2 – Partial thickness tears surgically treated without the addition of an implanted collagen scaffold; standard subacromial decompression and/or repair alone (control)
Control group
Active

Outcomes
Primary outcome [1] 279795 0
Supraspinatus tendon thickness as assessed by Magnetic Resonance Imaging (MRI)
Timepoint [1] 279795 0
at baseline and at 3, 6, and 12 months
Secondary outcome [1] 294451 0
Constant Murley Shoulder Score; a standardized means of measuring Pain, Activities of Daily Living, Range of Motion, and Power, on a 100 point scale. Pain and Activities of Daily Living are subjectively scored. Range of Motion and Power are objectively scored using standard relevant limb positions measured with a goniometer and a Dynamometer respectively. (Constant, CR, and AHG Murley. "A clinical method of functional assessment of the shoulder." Clin Orthop Relat Res 214 (1987): 160-64.)
Timepoint [1] 294451 0
at baseline and at 3, 6, and 12 months
Secondary outcome [2] 294452 0
ASES Shoulder Score; a standardized shoulder score derived from patient self-evaluations of pain, using a visual analog scale, and answering questions on activities of daily living . (Richards, RR, et al. "A standardized method for the assessment of shoulder function." J Shoulder Elbow Surg 3 (1994): 347-52.)
Timepoint [2] 294452 0
at baseline and at 3, 6, and 12 months
Secondary outcome [3] 294453 0
SF-36 quality of life assessment; derives a score from the answers to 36 survey questions (QualityMetric. SF-36v2 Health Survey. 2011)
Timepoint [3] 294453 0
at baseline and at 3, 6, and 12 months

Eligibility
Key inclusion criteria
Patients requiring surgical rotator cuff treatment of a partial- or small full-thickness tear of the supraspinatus tendon, as determined jointly by the surgeon and the patient.

Patients with chronic shoulder pain lasting longer than three months and resistant to pain medication and conservative treatment.

Patients over 40 years and under 65 years of age at time of surgery.

Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up and rehabilitation.

Patients who are capable of, and have given informed consent to their participation in the study.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with instability of the index shoulder.

Patients with grade 3 or greater chondromalacia of the index shoulder.

Patients who require concomitant procedures other than acromioplasty/subacromial decompression, acromioclavicular joint resection, or biceps tenotomy/tenodesis at least 2 cm distal to the site of supraspinatus tendon treatment.

Patients with evidence of calcification of the rotator cuff of the index shoulder.

Patients with evidence of grade 2 fatty infiltration or greater of the supraspinatus muscle of the index shoulder on a sagittal view of an MRI scan.

Patients with insulin dependent diabetes or other autoimmune or immune deficiency disorders.

Patients with genetic collagen disease.

Patients with chronic inflammatory disease.

Pregnant women or those seeking to become pregnant.

Patients who have had previous rotator cuff shoulder surgery on the index shoulder.

Patients with a history of oral steroid use in the last 2 months or injectable steroid use in the last 4 weeks.

Patients with an inability to complete post-surgery physical therapy or return for follow-up visits.

Patients who have been heavy smokers within the last 6 months (more than 20 cigarettes per day).

Patients with a known history of hypersensitivity to bovine-derived materials.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270043 0
Commercial sector/Industry
Name [1] 270043 0
Rotation Medical, Inc.
Country [1] 270043 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Rotation Medical, Inc.
Address
15350 25th Ave. No., Suite 100
Plymouth, MN 55447
Country
United States of America
Secondary sponsor category [1] 269014 0
None
Name [1] 269014 0
Address [1] 269014 0
Country [1] 269014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271997 0
Northern Sydney Central Coast
Ethics committee address [1] 271997 0
Level 2 Building 51, Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 271997 0
Australia
Date submitted for ethics approval [1] 271997 0
Approval date [1] 271997 0
01/08/2011
Ethics approval number [1] 271997 0
1105-169M
Ethics committee name [2] 271998 0
Sydney Adventist Hospital
Ethics committee address [2] 271998 0
185 Fox Valley Road
Wahroonga NSW 2076
Ethics committee country [2] 271998 0
Australia
Date submitted for ethics approval [2] 271998 0
Approval date [2] 271998 0
05/09/2011
Ethics approval number [2] 271998 0
2011-030
Ethics committee name [3] 271999 0
Macquarie University Hospital
Ethics committee address [3] 271999 0
3 Technology Place
Macquarie University NSW 2109
Ethics committee country [3] 271999 0
Australia
Date submitted for ethics approval [3] 271999 0
Approval date [3] 271999 0
13/10/2011
Ethics approval number [3] 271999 0
5201100784

Summary
Brief summary
The study hypothesis is that the addition of a surgically implanted collagen scaffold will structurally thicken the tendon, measured with MRI, compared with tendons that are treated with standard decompression and/or repair alone without the scaffold.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33273 0
Address 33273 0
Country 33273 0
Phone 33273 0
Fax 33273 0
Email 33273 0
Contact person for public queries
Name 16520 0
Jeff Sims
Address 16520 0
Rotation Medical, Inc
15350 25th Ave. Nor, Suite 100
Plymouth, MN 55447
Country 16520 0
United States of America
Phone 16520 0
+1 763 746 7502
Fax 16520 0
+1 763 746 7501
Email 16520 0
[email protected]
Contact person for scientific queries
Name 7448 0
Professor David H. Sonnabend
Address 7448 0
Royal North Shore Hospital
St Leonards NSW 2065
Country 7448 0
Australia
Phone 7448 0
+61 2 9926 7132
Fax 7448 0
+61 2 9926 6311
Email 7448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.