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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04450342




Registration number
NCT04450342
Ethics application status
Date submitted
24/06/2020
Date registered
29/06/2020

Titles & IDs
Public title
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
Scientific title
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone
Secondary ID [1] 0 0
REGENETEN.2020.01
Universal Trial Number (UTN)
Trial acronym
REGENETEN
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
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
Treatment: Surgery - Arthroscopic rotator cuff repair
Treatment: Devices - Arthroscopic rotator cuff repair for revision surgery

Experimental: ARCR augmented with REGENETEN™ Bioinductive Implant - During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.

Sham comparator: ARCR alone - The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing

Other: ARCR revision group - ARCR revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN


Treatment: Devices: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
The 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. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.

Treatment: Surgery: Arthroscopic rotator cuff repair
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.

Treatment: Devices: Arthroscopic rotator cuff repair for revision surgery
The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
6 months retear rate
Timepoint [1] 0 0
6 months post surgery
Secondary outcome [1] 0 0
Retear rate
Timepoint [1] 0 0
3, 6, 12, and 24 months
Secondary outcome [2] 0 0
Oxford Shoulder Score (OSS)
Timepoint [2] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [3] 0 0
Western Ontario Rotator Cuff (WORC)/Chinese version WORC (C-WORC) Index)
Timepoint [3] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [4] 0 0
Constant-Murley Score
Timepoint [4] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [5] 0 0
Subjective shoulder value (SSV)
Timepoint [5] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [6] 0 0
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
Timepoint [6] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [7] 0 0
Patient satisfaction Questionnaire Outcome
Timepoint [7] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [8] 0 0
Pain, Visual analog scale (VAS) Score
Timepoint [8] 0 0
Baseline, 2 weeks, 6 weeks, 3 and 6 months
Secondary outcome [9] 0 0
MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Sugaya Score postoperatively
Timepoint [9] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [10] 0 0
MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Goutallier Classification postoperatively
Timepoint [10] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [11] 0 0
Total tendon thickness, tendon length will be assessed by MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone postoperatively
Timepoint [11] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [12] 0 0
Size of retear: anteroposterior [AP]/mediolateral [ML]) postoperatively
Timepoint [12] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [13] 0 0
Shape of retear postoperatively
Timepoint [13] 0 0
Baseline, 3, 6, 12 and 24 months
Secondary outcome [14] 0 0
Outcome of Return to Work Questionnaire in ARCR augmented with REGENETEN versus ARCR alone
Timepoint [14] 0 0
Baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [15] 0 0
Cumulative duration of opioid use in ARCR augmented with REGENETEN versus ARCR alone
Timepoint [15] 0 0
2 weeks
Secondary outcome [16] 0 0
Total operative time ARCR augmented with REGENETEN versus ARCR alone
Timepoint [16] 0 0
Intra-operative time
Secondary outcome [17] 0 0
Sling type and mobilization time in ARCR augmented with REGENETEN versus ARCR alone
Timepoint [17] 0 0
3 months

Eligibility
Key inclusion criteria
1. Subject requires Arthroscopic rotator cuff repair (ARCR);
2. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (= 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a = 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as = 3 cm on arthroscopy using a calibrated probe to proceed;
3. Subject is > 40 years of age (no upper limit);
4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
2. Subjects with Samilson-Prieto osteoarthritis > 2;
3. Subjects with current or prior infection of the ipsilateral shoulder;
4. Subjects with known hypersensitivity to bovine-derived materials;
5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);
7. Subjects with an irreparable or partially reparable rotator cuff tear;
8. Subjects with a subscapularis tear requiring repair;
9. Subjects requiring a concomitant labral fixation procedure;
10. Subjects requiring a concomitant os acromiale fixation procedure;
11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
14. Subjects who are pregnant or breast feeding;
15. Subjects who are currently involved in any injury litigation or workers compensation claims;
16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;
17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation
18. 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 study including mental illness, mental retardation, and drug or alcohol abuse;
19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2023
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [2] 0 0
OrthoSport Victoria - Richmond
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Canada
State/province [8] 0 0
New Brunswick
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
France
State/province [10] 0 0
Boulogne-Billancourt
Country [11] 0 0
France
State/province [11] 0 0
Provence-Alpes-Côte d'Azur
Country [12] 0 0
France
State/province [12] 0 0
Montpellier
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Île-de-France
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Hong Kong
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zurich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Lancashire
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Merseyside
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Middlesex
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Nottinghamshire
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Warwickshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
West Midlands
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Chris Peach, MBBS MD FRCS (Tr&Orth)
Address 0 0
Manchester University NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04450342