Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000926932
Ethics application status
Approved
Date submitted
19/06/2020
Date registered
17/09/2020
Date last updated
28/09/2023
Date data sharing statement initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the post-operative clinical and radiological outcome between surgical rotator cuff repair and scaffold augmentation for symptomatic rotator cuff tears in the shoulder
Scientific title
Does Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improve Early Functional Recovery? A Randomized Controlled Trial
Secondary ID [1] 301557 0
None
Universal Trial Number (UTN)
U1111-1253-8038
Trial acronym
Partial ROtator Cuff Trial of REGENETEN (PROCTOR)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Rotator Cuff Tears 317922 0
Condition category
Condition code
Musculoskeletal 315959 315959 0 0
Other muscular and skeletal disorders
Injuries and Accidents 316378 316378 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective randomized controlled trial (RCT) seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (including arthroscopic decompression and take down of the partial thickness rotator cuff tendon tear with a double row surgical repair) versus scaffold augmentation (using the REGENETEN scaffold, including arthroscopic decompression with augmentation of the partial thickness rotator cuff tear with the REGENTEN bioinductive scaffold/implant) for symptomatic partial thickness rotator cuff tears in the shoulder.

Therefore, the 'intervention' is the REGENTEN bioinductive scaffold/implant.

Surgery in all cases will be undertaken by a qualified shoulder orthopaedic surgeon. There is no addition training required by the surgeon, having experience already with both interventions for some time in a routine clinical setting. Based on current clinical experience, the duration of both surgical procedures is similar and will take 45-60 minutes in duration. While both surgeries are undertaken under a general anaesthetic, atients will be discharged from hospital on the day of (or day after) surgery. This does not differ based on the two surgical interventions, though is more dictated by individual patient progression, tolerance and recovery after the anaesthetic.

The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the nursing team that is independent to the research study team and on-site for all surgeries).
Intervention code [1] 317855 0
Treatment: Surgery
Comparator / control treatment
This prospective randomized controlled trial (RCT) seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (including arthroscopic decompression and take down of the partial thickness rotator cuff tendon tear with a double row surgical repair) versus scaffold augmentation (using the REGENETEN scaffold, including arthroscopic decompression with augmentation of the partial thickness rotator cuff tear with the REGENTEN bioinductive scaffold/implant) for symptomatic partial thickness rotator cuff tears in the shoulder.

Therefore, the 'control' is the participant cohort undergoing arthroscopic decompression and take down of the partial thickness rotator cuff tendon tear with a double row surgical repair. This procedure is indeed considered 'usual' care in this setting of symptomatic partial-thickness rotator cuff tears.

Surgery will be undertaken by a qualified shoulder orthopaedic surgeon.
Control group
Active

Outcomes
Primary outcome [1] 324167 0
Western Ontario Rotator Cuff Index (WORC) - the WORC produces an overall composite score derived from five specific health/function domains, including physical symptoms, sport and recreation capacity, work ability, lifestyle concerns and emotional concerns, specifically due to the shoulder condition/state.
Timepoint [1] 324167 0
3 months post-surgery
Secondary outcome [1] 383903 0
American Shoulder and Elbow Surgeons (ASES) Score - ASES is employed to evaluate difficulty during a range of daily, occupational (if relevant) and recreational tasks, including dressing, washing, overhead activities and lifting.
Timepoint [1] 383903 0
24 months post-surgery
Secondary outcome [2] 383904 0
Visual Analogue Pain Scale (VAS)
Timepoint [2] 383904 0
24 months post-surgery
Secondary outcome [3] 383905 0
Single Assessment Numeric Evaluation (SANE) - the SANE is employed to determine how the patient rates their affected/operated and unaffected shoulders as a percentage of normal (0% to 100% scale with 100% being normal).
Timepoint [3] 383905 0
24 months post-surgery
Secondary outcome [4] 383906 0
Veteran’s Rand 12 (VR-12) - the VR-12 is employed to evaluate the patient’s perception of their general health, producing a Physical (PCS) and Mental (MCS) Component Score.
Timepoint [4] 383906 0
24 months post-surgery
Secondary outcome [5] 383907 0
Global Rating of Change (GRC) scale - the GRC is employed to evaluate the patient’s perceived post-operative status compared to before their surgery.
Timepoint [5] 383907 0
24 months post-surgery
Secondary outcome [6] 383908 0
Patient satisfaction - this questionnaire will be employed to investigate each patient’s level of satisfaction with the surgery overall, as well as their satisfaction with the surgery in relieving their shoulder pain, improving their ability to perform normal daily activities, improving their ability to return to recreational activities and improving their ability to participate in sport. A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [6] 383908 0
24 months post-surgery
Secondary outcome [7] 383909 0
Constant Shoulder Score - this is an overall composite score (scored from 0-100) that is calculated by summing three individual sub-scales, including a 'subjective' sub-scale (that includes questions on pain and activity limitations), a 'strength' sub-scale and a shoulder 'range of motion' sub-scale. While only the overall composite Constant Shoulder Score will be employed, the subjective component 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.
Timepoint [7] 383909 0
24 months post-surgery
Secondary outcome [8] 383910 0
Magnetic Resonance Imaging (MRI) - this will be employed to assess tendon integrity (the healing status of the torn tendon).
Timepoint [8] 383910 0
6, 12 and 24 months post-surgery
Secondary outcome [9] 384906 0
Surgical Complications - 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.
Timepoint [9] 384906 0
Intra-operatively
Secondary outcome [10] 384907 0
Shoulder re-injuries (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 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.
Timepoint [10] 384907 0
24 months post-surgery
Secondary outcome [11] 384908 0
Adverse Events - 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).
Timepoint [11] 384908 0
These are reviewed at every associated post-operative clinical time-point (including intra-operatively, as well as 2 weeks, 6 weeks and 3, 6, 12 and 24 months post-surgery).

Eligibility
Key inclusion criteria
Inclusion Criteria
• Age 35-75 years,
• Duration of symptoms (DOS) >3 months,
• Unsuccessful conservative treatment comprising physiotherapy and/or a corticosteroid injection,
• A high grade (50% or more) partial thickness rotator cuff tear as noted on a 3-Tesla MRI scan.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Revision surgery or multi-tendon tears/pathology,
• 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,
• Smoker,
• Known adverse reaction to bovine derived products.

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)
Once study eligibility has been determined and the patient has completed informed consent, patients recruited into this RCT will be randomly allocated in a 1:1 ratio to one of the two surgical study arms. Randomization will be undertaken via a Sealed Envelope, an online randomisation service (A=Regeneten, B=Surgical Repair). Following the determination of participant eligibility and participant consent, the researcher recruiting the participant will undertake the randomisation process accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a Sealed Envelope, an online randomisation service (A=Regeneten, B=Surgical Repair).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
An estimated sample size has been calculated based on pre-existing data and superiority in the primary end-point (the WORC score at 3 months post-surgery). This has indicated n=35 will be required in each group to power the study for superiority in the WORC at 3-months post-surgery, while n=38 per group would adequate power the comparison for secondary outcomes such as the ASES. To allow for attrition over the study period, a total sample size of n=90 will be recruited. It is anticipated that the patient cohort be recruited over a 12-month period, with follow up over 24 months (i.e. 3 years in total).

Firstly, the mean (SD, range) of all subjective and objective measures collected will be presented for the designated pre- and post-operative time-points. Repeated measures Analysis of Variance (ANOVA) will be employed to evaluate change over the pre- and post-operative timeline in all clinical measures, and between groups. The number of respondents reporting each satisfaction score (Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied) across each of the Satisfaction items will be reported. 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 23.0, SPSS Inc., USA), while statistical significance was determined at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
24/02/2021
Date of last participant enrolment
Anticipated
24/02/2025
Actual
Date of last data collection
Anticipated
24/05/2027
Actual
Sample size
Target
90
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 16926 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 16927 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [3] 16929 0
Epworth Richmond - Richmond
Recruitment hospital [4] 16930 0
Epworth Hawthorn - Hawthorn
Recruitment hospital [5] 16931 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 30584 0
6150 - Murdoch
Recruitment postcode(s) [2] 30585 0
6008 - Subiaco
Recruitment postcode(s) [3] 30587 0
3121 - Richmond
Recruitment postcode(s) [4] 30588 0
3122 - Hawthorn
Recruitment postcode(s) [5] 30589 0
2109 - Macquarie Park
Recruitment outside Australia
Country [1] 22680 0
United States of America
State/province [1] 22680 0
Philadelphia

Funding & Sponsors
Funding source category [1] 305990 0
Commercial sector/Industry
Name [1] 305990 0
Smith and Nephew
Country [1] 305990 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Smith and Nephew
Address
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016
Country
United States of America
Secondary sponsor category [1] 306451 0
None
Name [1] 306451 0
Address [1] 306451 0
Country [1] 306451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306229 0
St John of God Health Care HREC
Ethics committee address [1] 306229 0
SJGHC Human Research Ethics Committee
Suite H203, Level 2
St John of God Subiaco Hospital
12 Salvado Rd
SUBIACO Western Australia 6008
Ethics committee country [1] 306229 0
Australia
Date submitted for ethics approval [1] 306229 0
10/07/2020
Approval date [1] 306229 0
12/08/2020
Ethics approval number [1] 306229 0

Summary
Brief summary
This study seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (current standard, control arm) versus scaffold augmentation (using the REGENETEN scaffold, experimental arm) for symptomatic partial thickness rotator cuff tears in the shoulder. Patient outcomes will be collected over a 24-month post-operative period and will include a range of subjective and functional outcomes, radiological measures and patient satisfaction. It is hypothesized that using the REGENETEN scaffold to augment/cover the symptomatic partial thickness rotator cuff tear will lead to improved early post-operative functional recovery, compared to the current standard surgical repair.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103174 0
Prof Allan Wang
Address 103174 0
St John of God Murdoch Clinic
Suite 10, 100 Murdoch Drive
Murdoch Western Australia 6150
Country 103174 0
Australia
Phone 103174 0
+61 8 6332 6390
Fax 103174 0
Email 103174 0
[email protected]
Contact person for public queries
Name 103175 0
Dr Jay Ebert
Address 103175 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, Western Australia, 6009
Country 103175 0
Australia
Phone 103175 0
+61 8 9386 9961
Fax 103175 0
Email 103175 0
[email protected]
Contact person for scientific queries
Name 103176 0
Prof Allan Wang
Address 103176 0
St John of God Murdoch Clinic
Suite 10, 100 Murdoch Drive
Murdoch Western Australia 6150
Country 103176 0
Australia
Phone 103176 0
+61 8 6332 6390
Fax 103176 0
Email 103176 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


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.