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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06857084
Registration number
NCT06857084
Ethics application status
Date submitted
26/02/2025
Date registered
4/03/2025
Date last updated
4/03/2025
Titles & IDs
Public title
Evaluation of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: a Prospective, Multi-Center Global Registry
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Scientific title
Evaluation of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN? Bioinductive Implant: a Prospective, Multi-Center Global Registry
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Secondary ID [1]
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REGENETEN Global Registry
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Universal Trial Number (UTN)
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Trial acronym
RePaRe
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Injuries
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
Rotator cuff repair using REGENETEN - Patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant
Treatment: Devices: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
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Assessment method [1]
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The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
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Timepoint [1]
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Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Primary outcome [2]
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Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
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Assessment method [2]
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Quick DASH (Disabilities of Arm, Shoulder and Hand) is designed to measure physical function and symptoms. It assesses 11 items, with scores ranging from 0 to 100 where 0 indicates no disability (i.e., better outcome) and 100 indicates most severe disability (i.e., worse outcome).
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Timepoint [2]
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Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Primary outcome [3]
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Oxford Shoulder Score (OSS)
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Assessment method [3]
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The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
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Timepoint [3]
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Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Primary outcome [4]
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Pain, Visual Analog Scale (VAS) Score
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Assessment method [4]
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Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
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Timepoint [4]
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Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Primary outcome [5]
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Single Assessment Numeric Evaluation (SANE) Score
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Assessment method [5]
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The Single Assessment Numeric Evaluation (SANE) is a simple but effective measure where patients rate their shoulder condition as a percentage (0-100%), where 100% being completely normal and 0% being the worst condition imaginable.
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Timepoint [5]
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Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [1]
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Retear Rate
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Assessment method [1]
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Cumulative 3 months, 6 months, 12 months, and 24 months retear rate. Failure is defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
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Timepoint [1]
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3 months, 6 months, 12 months, and 24 months
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Secondary outcome [2]
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Post-operative Recovery: Sling Type and Mobilization Time
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Assessment method [2]
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The type of sling will be collected and presented for each treatment arm summarizing if standard sling, shoulder immobilizer, abduction sling, ER sling, or other were advised. Mobilization time will be calculated for both arms.
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Timepoint [2]
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2 weeks
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Secondary outcome [3]
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Post-operative Recovery: Return to Work
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Assessment method [3]
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Return to work questionnaires are collected at baseline and at 6 months post-op. At baseline, information on working arrangements are established: * Occupation status: Full time/part time/ retired * Occupation type: Sedentary/labor intensive * Impact of their diagnosis on their work performance: negative impact/no change At 6 months, information on changes to working arrangements is established: * Changes to occupation status * Returned to work and at what level: not returned due to procedure, not returned for other reasons, retired, lower level, same level, higher level * Time taken to return to work in days/weeks/months (if applicable)
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Timepoint [3]
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Baseline and 6 months
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Eligibility
Key inclusion criteria
* Subject requires Arthroscopic rotator cuff repair (ARCR);
* Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.
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Minimum age
18
Years
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Maximum age
No limit
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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
* Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
* Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Orthopaedic Group - Windsor
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Recruitment postcode(s) [1]
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3181 - Windsor
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Aisne
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Country [2]
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Germany
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State/province [2]
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Rhine
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Country [3]
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Germany
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State/province [3]
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Düsseldorf
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Country [4]
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Germany
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State/province [4]
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Erlangen
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Country [5]
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Germany
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State/province [5]
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Heidelberg
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Country [6]
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Germany
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State/province [6]
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Herne
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Country [7]
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Germany
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State/province [7]
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Stadtallendorf
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Country [8]
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Italy
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State/province [8]
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Apulia
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Country [9]
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United Kingdom
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State/province [9]
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Greater Manchester
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Country [10]
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United Kingdom
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State/province [10]
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Hertordshire
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Country [11]
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United Kingdom
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State/province [11]
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Hove
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Country [12]
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United Kingdom
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State/province [12]
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Lancashire
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Country [13]
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United Kingdom
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State/province [13]
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Lincolnshire
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Country [14]
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United Kingdom
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State/province [14]
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Somerset
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Country [15]
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United Kingdom
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State/province [15]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Smith & Nephew Asia Pacific Pte
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN? Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
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Trial website
https://clinicaltrials.gov/study/NCT06857084
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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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Scott Reid
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Address
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Smith & Nephew, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sarah Turner
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Address
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Country
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Phone
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+44 7583 029252
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06857084
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