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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

Titles & IDs
Public title
Evaluation of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: a Prospective, Multi-Center Global Registry
Scientific title
Evaluation of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN? Bioinductive Implant: a Prospective, Multi-Center Global Registry
Secondary ID [1] 0 0
REGENETEN Global Registry
Universal Trial Number (UTN)
Trial acronym
RePaRe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Injuries 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
Timepoint [1] 0 0
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Primary outcome [2] 0 0
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
Timepoint [2] 0 0
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Primary outcome [3] 0 0
Oxford Shoulder Score (OSS)
Timepoint [3] 0 0
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Primary outcome [4] 0 0
Pain, Visual Analog Scale (VAS) Score
Timepoint [4] 0 0
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Primary outcome [5] 0 0
Single Assessment Numeric Evaluation (SANE) Score
Timepoint [5] 0 0
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [1] 0 0
Retear Rate
Timepoint [1] 0 0
3 months, 6 months, 12 months, and 24 months
Secondary outcome [2] 0 0
Post-operative Recovery: Sling Type and Mobilization Time
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Post-operative Recovery: Return to Work
Timepoint [3] 0 0
Baseline and 6 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Orthopaedic Group - Windsor
Recruitment postcode(s) [1] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Aisne
Country [2] 0 0
Germany
State/province [2] 0 0
Rhine
Country [3] 0 0
Germany
State/province [3] 0 0
Düsseldorf
Country [4] 0 0
Germany
State/province [4] 0 0
Erlangen
Country [5] 0 0
Germany
State/province [5] 0 0
Heidelberg
Country [6] 0 0
Germany
State/province [6] 0 0
Herne
Country [7] 0 0
Germany
State/province [7] 0 0
Stadtallendorf
Country [8] 0 0
Italy
State/province [8] 0 0
Apulia
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Greater Manchester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Hertordshire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Hove
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Lancashire
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Lincolnshire
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Somerset
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Smith & Nephew Asia Pacific Pte
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Scott Reid
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Turner
Address 0 0
Country 0 0
Phone 0 0
+44 7583 029252
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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