Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000377437p
Ethics application status
Not yet submitted
Date submitted
6/04/2025
Date registered
29/04/2025
Date last updated
29/04/2025
Date data sharing statement initially provided
29/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmentation of large to massive rotator cuff tears with dermal allograft: a single blinded randomised controlled trial
Scientific title
Augmentation of large to massive rotator cuff tears with dermal allograft: a single blinded randomised controlled trial
Secondary ID [1] 314143 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tears 336957 0
Condition category
Condition code
Musculoskeletal 333429 333429 0 0
Other muscular and skeletal disorders
Surgery 333430 333430 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, single-blinded, randomised controlled trial (RCT) designed to evaluate the efficacy of the ArthroFlex dermal allograft patch augmentation in the surgical repair of large (>2.5 cm) to massive rotator cuff tears. Participants will be randomized (1:1) into two groups: standard rotator cuff repair (control) or standard rotator cuff repair with ArthroFlex augmentation (intervention).

The ArthroFlex dermal allograft patch is a biohospitable, acellular dermal extracellular matrix intended for supplemental support and covering for soft-tissue repairs. Following the completion of the standard rotator cuff repair (i.e. the control group), patients randomised to the intervention group will then receive augmentation of their cuff repair using the Arthroflex patch, which is inserted arthroscopically via a lateral shoulder portal using the Arthrex Graft Spreader. Before insertion, the graft is prepared with luggage tag type sutures using Arthrex Fibrelink sutures. The Graft Spreader then positions the graft to cover the rotator cuff repair and associated sutures. The Arthroflex patch is then secured in place medially with 2 or 3 Arthrex Fibrestich RC anchors. Once secured medially the medial Fibrelink sutures are removed and those on the lateral corners are secured into place using two 3.5mm PushLock anchors to secure the graft laterally.

The surgical time for both techniques remains similar, with the additional ArthroFlex augmentation (intervention) adding approximately 5 minutes to the overall surgical time. The administration of the Arthroflex patch in the intervention group will be confirmed at the time of surgery, and following surgery as per the official completed operation record.

Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual therapist, and the same across both groups.
Intervention code [1] 330729 0
Treatment: Surgery
Comparator / control treatment
The control group will undergo the current standard clinical practice, which is rotator cuff repair without ArthroFlex augmentation.
Control group
Active

Outcomes
Primary outcome [1] 341002 0
Re-tears
Timepoint [1] 341002 0
24-months post-surgery
Secondary outcome [1] 445750 0
Surgical Complications
Timepoint [1] 445750 0
Intra-operatively
Secondary outcome [2] 445751 0
Adverse Events
Timepoint [2] 445751 0
These are reviewed at every associated post-operative clinical time-point (including intra-operatively, as well as 2 weeks and 3, 6, 12 and 24 months post-surgery).
Secondary outcome [3] 445752 0
Quality of tendon healing (tendon integrity)
Timepoint [3] 445752 0
6, 12 and 24 months post-surgery
Secondary outcome [4] 445753 0
Shoulder pain and function composite score
Timepoint [4] 445753 0
24-months post-surgery
Secondary outcome [5] 445754 0
Self-reported score of shoulder normality
Timepoint [5] 445754 0
24-months post-surgery
Secondary outcome [6] 445755 0
Frequency of shoulder pain
Timepoint [6] 445755 0
24-months post-surgery
Secondary outcome [7] 445756 0
Patient-reported physical health status
Timepoint [7] 445756 0
24-months post-surgery
Secondary outcome [8] 445758 0
Functional Shoulder Status
Timepoint [8] 445758 0
24-months post-surgery
Secondary outcome [9] 445759 0
Shoulder strength analysis
Timepoint [9] 445759 0
24-months post-surgery
Secondary outcome [10] 446517 0
Severity of shoulder pain
Timepoint [10] 446517 0
24-months post-surgery
Secondary outcome [11] 446518 0
Patient-reported mental health status
Timepoint [11] 446518 0
24-months post-surgery

Eligibility
Key inclusion criteria
Inclusion Criteria
- Adults aged 30–80 years with MRI-confirmed large (>2.5 cm) or massive rotator cuff tears involving at least two tendons.
- Suitable candidates for rotator cuff repair surgery.
- Willingness to comply with follow-up visits and assessments.
- Primary procedures as well as previous failed rotator cuff repairs (primary and revision repairs to be included).
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
- Irreparable rotator cuff tears (insufficient tissue for primary repair).
- Goutallier classification of fatty degeneration grades 3 and 4.
- Significant glenohumeral arthritis with Hamada grade 3, 4 and 5.
- Large subscapularis tears, LaFosse grades 3, 4 and 5.
- Cervical pathology and/or concomitant upper limb pathology (e.g. arthritis, nerve compression).
- Adhesive capsulitis, clinical shoulder instability or previous fracture.
- Infection.
- Pregnancy and lactation.
- Professional athlete.
- Worker’s compensation or compensable claim.
- Substance abuse or current mental illness.
- Smokers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned (1:1 ratio) to one of two groups: 1) standard rotator cuff repair without augmentation (control group), or 2) standard rotator cuff repair augmented with the ArthroFlex dermal allograft patch (intervention group). Randomisation will occur at the time of surgery, once the large to massive tear has been confirmed intra-operatively and subsequently repaired. Sealed randomised envelopes will be employed to indicate whether the patient is in the control or intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Firstly, the mean (SD, range) of all subjective and objective measures collected will be presented for the designated pre- and post-operative time-points. Continuous outcomes (such as PROMs and strength measures) will be analysed using mixed-effects models to account for repeated measures. Re-tear rates will be assessed between groups using chi-square tests. The number (and type) of surgical complications, post-operative adverse events, re-injuries and/or re-operations will be presented. The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months) will be reported. Where appropriate, statistical analysis will be performed using SPSS software (SPSS, Version 29.0, SPSS Inc., USA), while statistical significance was determined at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
1/07/2029
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318653 0
Commercial sector/Industry
Name [1] 318653 0
Arthrex
Country [1] 318653 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Perth Orthopaedic and Sports Medicine Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 321074 0
None
Name [1] 321074 0
Address [1] 321074 0
Country [1] 321074 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317267 0
Ramsay Health Care WA / SA Human Research Ethics Committee
Ethics committee address [1] 317267 0
Ethics committee country [1] 317267 0
Australia
Date submitted for ethics approval [1] 317267 0
30/04/2025
Approval date [1] 317267 0
Ethics approval number [1] 317267 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140506 0
Mr Travis Falconer
Address 140506 0
Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
Country 140506 0
Australia
Phone 140506 0
+61 8 9212 4200
Fax 140506 0
Email 140506 0
[email protected]
Contact person for public queries
Name 140507 0
Travis Falconer
Address 140507 0
Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
Country 140507 0
Australia
Phone 140507 0
+61 8 9212 4200
Fax 140507 0
Email 140507 0
[email protected]
Contact person for scientific queries
Name 140508 0
Jay Ebert
Address 140508 0
Perth Orthopaedic and Sports Medicine Research Institute, Level 1/1 Havelock St, West Perth WA 6005
Country 140508 0
Australia
Phone 140508 0
+61 8 9212 4200
Fax 140508 0
Email 140508 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.