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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
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Scientific title
Augmentation of large to massive rotator cuff tears with dermal allograft: a single blinded randomised controlled trial
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Secondary ID [1]
314143
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tears
336957
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Condition category
Condition code
Musculoskeletal
333429
333429
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0
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Other muscular and skeletal disorders
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Surgery
333430
333430
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330729
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Treatment: Surgery
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Comparator / control treatment
The control group will undergo the current standard clinical practice, which is rotator cuff repair without ArthroFlex augmentation.
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Control group
Active
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Outcomes
Primary outcome [1]
341002
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Re-tears
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Assessment method [1]
341002
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Rotator cuff re-tears (and associated re-operations) - information on the nature (i.e. mechanism) and timing of each re-injury, together with the timing of subsequent re-operation, will be be reported. Should these be reported at the time of a designated study monitoring visit, they will be discussed with the patient and the treating orthopaedic surgeon, and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information if required. Should these be experienced and reported outside (or between) designated study monitoring visits, then the treating surgeon will consult the patient as would be the case in routine clinical practice. Again, the nature of the re-injury, further investigations and/or treatment will be discussed with the patient and the treating orthopaedic surgeon, and further reported and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information required.
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Timepoint [1]
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24-months post-surgery
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Secondary outcome [1]
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Surgical Complications
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Assessment method [1]
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The type of complication (outside of the routine operative pathway) and the overall number of complications will be reported. These will be documented and obtained from the surgical operation notes, as well as via discussion with the treating orthopaedic surgeon.
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Timepoint [1]
445750
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Intra-operatively
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Secondary outcome [2]
445751
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Adverse Events
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Assessment method [2]
445751
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Information on the type, severity and timing of each adverse event will be reported. Should these be reported at the time of a designated study monitoring visit, they will be discussed with the patient and the treating orthopaedic surgeon, and documented accordingly based on professional clinical examination from the treating orthopaedic specialist. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information if required. Should these be experienced and reported outside (or between) designated study monitoring visits, then the treating surgeon will consult the patient as would be the case in routine clinical practice. Again, the nature of the event, further investigations and/or treatment will be discussed with the patient and the treating orthopaedic surgeon, and further reported and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information required. Adverse events will be graded as follows: • Mild (Grade 1): Transient or mild discomfort; no limitation in activity; no intervention or therapy required (may include, though not limited to, events such as nausea). • Moderate (Grade 2): Mild to moderate limitation in activity; some assistance may be needed; no or minimal medical intervention/therapy required (may include, though not limited to, events such as infection at the incision site). • Severe (Grade 3): Marked limitation in activity; some assistance usually required; medical intervention/therapy required; hospitalization possible (may include, though not limited to, events such as transient nerve damage which may cause numbness, tingling, pain, and weakness). • Extreme (Grade 4): Extreme limitation in activity; significant assistance required; significant medical intervention/therapy required; hospitalization or hospice care probable; potentially life-threatening (may include, though not limited to, events such as blood clots, haemorrhaging and/or internal bleeding).
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Timepoint [2]
445751
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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).
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Secondary outcome [3]
445752
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Quality of tendon healing (tendon integrity)
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Assessment method [3]
445752
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Magnetic Resonance Imaging (MRI) assessment will be employed to evaluate tendon integrity. Tendon-bone integration and healing quality will include the degree of tendon-bone attachment, signal intensity changes in the repaired tissue, and presence of fatty infiltration. Repairs will also be categorised as intact or failed (partial or complete re-tear) based on standardized MRI criteria using the Sugaya classification. MRI scans will be evaluated by an independent musculoskeletal radiologist.
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Timepoint [3]
445752
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6, 12 and 24 months post-surgery
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Secondary outcome [4]
445753
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Shoulder pain and function composite score
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Assessment method [4]
445753
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The American Shoulder and Elbow Surgeons (ASES) Score will be employed as a more comprehensive score of shoulder pain and function. The combined ASES score ranges from 0-100, with a higher score indicating better outcomes.
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Timepoint [4]
445753
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24-months post-surgery
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Secondary outcome [5]
445754
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Self-reported score of shoulder normality
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Assessment method [5]
445754
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The Single Assessment Numeric Evaluation (SANE) will be used to determine how the patient rates their operated and unaffected shoulders as a percentage of normal (0% to 100% scale with 100% being normal).
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Timepoint [5]
445754
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24-months post-surgery
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Secondary outcome [6]
445755
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Frequency of shoulder pain
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Assessment method [6]
445755
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A Visual Analogue Pain Scale (VAS) for pain frequency (VAS-F) will be employed, on a score of 0-10 (0 = no pain, 10 = highly frequent pain)
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Timepoint [6]
445755
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24-months post-surgery
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Secondary outcome [7]
445756
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Patient-reported physical health status
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Assessment method [7]
445756
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The Physical Component Subscale (PCS) of the Veteran’s Rand 12 (VR-12) will be employed to evaluate the patient’s perception of their general physical health.
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Timepoint [7]
445756
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24-months post-surgery
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Secondary outcome [8]
445758
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Functional Shoulder Status
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Assessment method [8]
445758
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The Constant Shoulder Score will be employed as a measure of overall functional shoulder status. The subjective component of the Constant score is allotted a total of 35 points and evaluates patient-reported pain (15 points), as well as how the patient’s shoulder condition affects their ability to undertake occupational, leisure and other daily activities (20 points). Active range of motion is allotted 40 points consisting of forward flexion (10 points), abduction (10 points), functional external rotation (10 points) and internal rotation (10 points). Maximal pain-free isometric shoulder abduction strength in 90° of shoulder abduction in the scapular plane is allotted 25 points. Finally, a ‘total’ Constant score will be calculated (0-100) by summing the three individual sub-scales. The MDC for the Constant score has been reported as 18 points for rotator cuff tears.
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Timepoint [8]
445758
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24-months post-surgery
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Secondary outcome [9]
445759
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Shoulder strength analysis
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Assessment method [9]
445759
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A dedicated shoulder strength analysis will be undertaken using an isokinetic dynamometer (Humac Dynamometer) to assess shoulder internal, external rotation and abduction peak force and endurance.
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Timepoint [9]
445759
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24-months post-surgery
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Secondary outcome [10]
446517
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Severity of shoulder pain
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Assessment method [10]
446517
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A Visual Analogue Pain Scale (VAS) for pain severity (VAS-S) will be employed, on a score of 0-10 (0 = no pain, 10 = most severe pain).
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Timepoint [10]
446517
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24-months post-surgery
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Secondary outcome [11]
446518
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Patient-reported mental health status
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Assessment method [11]
446518
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The Mental Component Subscale (MCS) of the Veteran’s Rand 12 (VR-12) will be employed to evaluate the patient’s perception of their general mental health.
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Timepoint [11]
446518
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24-months post-surgery
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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).
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Minimum age
30
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a random number generator.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
1/07/2027
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Actual
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Date of last data collection
Anticipated
1/07/2029
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Actual
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Sample size
Target
84
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
318653
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Commercial sector/Industry
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Name [1]
318653
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Arthrex
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Address [1]
318653
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Country [1]
318653
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United States of America
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Primary sponsor type
Charities/Societies/Foundations
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Name
Perth Orthopaedic and Sports Medicine Research Foundation
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Address
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Country
Australia
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Secondary sponsor category [1]
321074
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None
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Name [1]
321074
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Address [1]
321074
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Country [1]
321074
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
317267
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Ramsay Health Care WA / SA Human Research Ethics Committee
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Ethics committee address [1]
317267
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https://www.ramsayhealth.com.au/Ramsay-Research/Reseach-Ethics-at-Ramsay
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Ethics committee country [1]
317267
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Australia
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Date submitted for ethics approval [1]
317267
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30/04/2025
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Approval date [1]
317267
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Ethics approval number [1]
317267
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Summary
Brief summary
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 repair (control) or repair with ArthroFlex augmentation (intervention). Outcome measures, including MRI-based structural integrity, functional scores and strength analysis, will be assessed at 6-, 12-, and 24-months. Patients and outcome assessors will be blinded to group allocation, while the surgical team performing the procedure will not be blinded due to the nature of the intervention. The primary hypothesis is that patients receiving ArthroFlex augmentation will demonstrate superior pain and functional outcomes, compared to standard repair technique.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Travis Falconer
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Address
140506
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Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
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Country
140506
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Australia
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Phone
140506
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+61 8 9212 4200
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Fax
140506
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Email
140506
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[email protected]
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Contact person for public queries
Name
140507
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Travis Falconer
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Address
140507
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Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
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Country
140507
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Australia
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Phone
140507
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+61 8 9212 4200
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Fax
140507
0
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Email
140507
0
[email protected]
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Contact person for scientific queries
Name
140508
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Jay Ebert
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Address
140508
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Perth Orthopaedic and Sports Medicine Research Institute, Level 1/1 Havelock St, West Perth WA 6005
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Country
140508
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Australia
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Phone
140508
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+61 8 9212 4200
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Fax
140508
0
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Email
140508
0
[email protected]
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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.
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