Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000765921
Ethics application status
Approved
Date submitted
28/05/2020
Date registered
27/07/2020
Date last updated
1/12/2023
Date data sharing statement initially provided
27/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of the effect of muscle advancement on tendon healing, pain and range of motion in patients undergoing rotator cuff repair for massive tears.
Scientific title
Muscle Advancement and its effect on post-operative tendon healing, pain and range of motion in patients undergoing repair of Massive rotator cuff tears and Arthroscopy: An Observational Case Series
Secondary ID [1] 301393 0
SSRI22020-1310-1706
Universal Trial Number (UTN)
U1111-1252-7360
Trial acronym
Muscle Advancement and its effect on post-operative tendon healing, pain and range of motion in patients undergoing repair of Massive rotator cuff tears and Arthroscopy (MAMA)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain after repair for massive rotator cuff tears 317649 0
Range of motion after repair for massive rotator cuff tears 317805 0
Tendon healing after repair for massive rotator cuff tears 317806 0
Condition category
Condition code
Musculoskeletal 315731 315731 0 0
Other muscular and skeletal disorders
Surgery 315732 315732 0 0
Surgical techniques
Injuries and Accidents 315733 315733 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
50 consecutive patients undergoing surgery for a massive rotator cuff tear will each receive an additional surgical step called muscle advancement. Essentially their shoulder muscle will be detached then advanced (pulled or “slid”) then reattached. This extra step is designed to reduce tension on the surgical site which is one of the proven causes of this type of surgery not being successful. The rest of the surgery and rehabilitation will proceed as usual for rotator cuff repair.

The addition of the muscle advancement technique will add approximaetly 15 minutes to the typical rotator cuff surgical time increasing it from (on average) 90 minutes to 105 minutes.To ensure fidelity to the intervention, all 3 surgeons will follow the same technique which will be confirmed using an intraoperative checklist. All 50 patients in this observational study will receive the additional surgical technique.

Patients will be observed pre-operatively and assessed in terms of tendon quality (as seen on MRI), pain, range of motion and the function their affected shoulder allows. They will then be assessed post-operatively at 2 weeks (pain only), 8 weeks (pain, range of motion and shoulder function), 24 weeks (pain, range of motion, shoulder function and cuff healing on MRI) and 52 weeks (pain, range of motion and shoulder function).
Intervention code [1] 317954 0
Not applicable
Comparator / control treatment
This study will use historical age-matched control data extracted from the medical records of patients who underwent standard surgical repair without the addition of muscle advancement by the study surgeons over the last ten years ie between 2010-2020 with the final surgery date being 01/01/2020.
Control group
Historical

Outcomes
Primary outcome [1] 323945 0
Tendon healing as seen on MRI and classified using the technique described by Sugaya et al (2007).
Timepoint [1] 323945 0
Within 9 months post-operatively.
Primary outcome [2] 323946 0
Shoulder Range of Motion assessed using a goniometer.
Timepoint [2] 323946 0
Within one day pre-surgery then weeks 2, 8, 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.
Primary outcome [3] 324075 0
Overall failure rate assessed using post-operative MRI and expressed as an overall%. Traditionally the failure rate for repair of massive rotator cuff tears has been between 25 and 50%.
Timepoint [3] 324075 0
Weeks 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.
Secondary outcome [1] 383386 0
Pain assessed using the 100mm visual analogue scale. This is a primary outcome.
Timepoint [1] 383386 0
Within one day before surgery then weeks 2, 8, 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.
Secondary outcome [2] 383387 0
Shoulder function assessed using the WORC (Western Ontario Rotator Cuff index). This is a primary outcome.
Timepoint [2] 383387 0
Within one day before surgery then weeks 2, 8, 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.
Secondary outcome [3] 383684 0
Shoulder function assessed using the ASES (American Shoulder and Elbow Society Score). This is a primary outcome.
Timepoint [3] 383684 0
Within one day before surgery then weeks 2, 8, 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.
Secondary outcome [4] 383685 0
Shoulder function assessed using the Constant score. This is a primary outcome.
Timepoint [4] 383685 0
Within one day before surgery then weeks 24 and 52 weeks post-surgery, with 52 weeks being the primary endpoint.

Eligibility
Key inclusion criteria
1. Patients who have consented for shoulder arthroscopy and rotator cuff repair under one of the investigators.
2. Patients who are capable of and have given informed consent for their participation in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with incomplete rotator cuff tears
2. Patients with isolated subscapularis or supraspinatus tendon tears
3. Patients with a failed rotator cuff repair requiring revision
4. Patients with irreparable rotator cuff tears
5. Patients with acute post trauma rotator cuff tears
6. Patients whose rotator cuff tears have a neurologic lesion such as cervical spondylotic myelopathy
7. Patients with glenohumeral osteoarthritis or rheumatoid arthritis
8. Patients with history of infection in the affected shoulder

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Correlation analysis, including univariate and multivariate analyses will be used to determine the correlation between muscle advancement technique and the selected outcome criteria. P value <0.05 will be considered as statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/07/2020
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
50
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16771 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 16772 0
Mater Sydney - North Sydney
Recruitment hospital [3] 16773 0
Dubbo Private Hospital - Dubbo
Recruitment postcode(s) [1] 30394 0
2065 - St Leonards
Recruitment postcode(s) [2] 30395 0
2060 - North Sydney
Recruitment postcode(s) [3] 30396 0
2830 - Dubbo

Funding & Sponsors
Funding source category [1] 305835 0
Other Collaborative groups
Name [1] 305835 0
Sydney Shoulder Research Institute
Country [1] 305835 0
Australia
Primary sponsor type
Individual
Name
Dr Benjamin Cass
Address
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 306279 0
None
Name [1] 306279 0
Address [1] 306279 0
Country [1] 306279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306099 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [1] 306099 0
Research Office
Level 6
de Lacy Building
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 306099 0
Australia
Date submitted for ethics approval [1] 306099 0
19/05/2020
Approval date [1] 306099 0
17/07/2020
Ethics approval number [1] 306099 0
2020/ETH01267

Summary
Brief summary
Traditionally the failure rate for repair of massive rotator cuff tears has been between 25 and 50%. The aim of this study is to test the hypothesis that adding the technique of muscle advancement to standard rotator cuff repair improves this failure rate along with postoperative shoulder range of motion, pain and function. 50 patients who require surgery for massive rotator cuff tears will undergo repair that includes the addition of the muscle advancement technique. While this will extend their surgery time by around 15 minutes, the rest of their surgery and rehabilitation will proceed as standard. We will use historical age-matched control data extracted from the medical records of patients who have undergone standard surgical repair (ie without muscle advancement) by the study surgeons over the last ten years.
Trial website
In the process of being listed on www.ssri.net.au (the Sponsor's website).
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102702 0
Dr Benjamin Cass
Address 102702 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 102702 0
Australia
Phone 102702 0
+61 2 9460 8888
Fax 102702 0
+61 2 9460 6064
Email 102702 0
[email protected]
Contact person for public queries
Name 102703 0
Jasmin Gwynne
Address 102703 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 102703 0
Australia
Phone 102703 0
+61 2 9460 8813
Fax 102703 0
+61 2 9460 6064
Email 102703 0
[email protected]
Contact person for scientific queries
Name 102704 0
Benjamin Cass
Address 102704 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 102704 0
Australia
Phone 102704 0
+61 2 9460 8888
Fax 102704 0
+61 2 9460 6064
Email 102704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
After analysis is completed, all study data will be deidentified, stored confidentially and not be used for any further research unless further ethics approval is granted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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