Clinical trial NCT04450342: REGENETEN™ Bioinductive Implant System in Full-thickness Tears
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Rotator cuff tendon
Full thickness tears
REGENETEN Bioinductive Implant System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 119
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.

Detailed description: This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Retear Rate at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Retears at 3 Months, 12 Months, and 24 Months
timeFrame: 3 months, 12 months, and 24 months
measure: Oxford Shoulder Score (OSS)
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Constant-Murley Score
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Subjective Shoulder Value (SSV)
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: Medical Care
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Pain - Visual Analog Scale (VAS) Score
timeFrame: 2 weeks, 6 weeks, 3 months and 6 months
measure: MRI Tendon Findings: Supraspinatus Sugaya Score
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: MRI Tendon Findings: Infraspinatus Sugaya Score
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: MRI Tendon Findings: Supraspinatus Goutallier Classification
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: MRI Tendon Findings: Infraspinatus Goutallier Classification
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Total Tendon Thickness
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Total Tendon Length
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
timeFrame: Day 0, 3 months and 6 months
measure: Size of Retear: Anteroposterior (AP) Length
timeFrame: Day 0, 3 months and 6 months
measure: Size of Retear: Mediolateral (ML) Length
timeFrame: Day 0, 3 months and 6 months
measure: Shape of Retear: Operative Visit
timeFrame: Day 0
measure: Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
timeFrame: 3 months, 6 months, 12 months and 24 months
measure: Return to Work Questionnaire
timeFrame: 2 weeks, 6 weeks, 3 months and 6 months
measure: Return to Work Questionnaire: Reason for Not Getting Back to Work
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
measure: Return to Work Questionnaire: Reason Couldn't Return to Activities
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
measure: Return to Work Questionnaire: Time Off
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
measure: Return to Work Questionnaire: Duration Away From Work (Days)
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
measure: Duration of Opioid Use
timeFrame: Following surgery, up to 14 days
measure: Opioid Use for More Than 5 Days Post-Surgery
timeFrame: Following surgery, up to 14 days
measure: Total Operative Time
timeFrame: Intraoperative
measure: Sling Type
timeFrame: up to 3 months
measure: Mobilization Time in Sling
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: DeWitt
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bedford
country: United States
facility: Texas Orthopedic Specialists
state: Texas
city: The Woodlands
country: United States
facility: Houston Methodist The Woodlands
state: Texas
city: Ashland
country: United States
facility: Ashland Memorial Medical Center
state: Wisconsin
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Richmond
country: Australia
facility: OrthoSport Victoria
state: Victoria
city: Saint John
country: Canada
facility: Saint John Orthopaedics
state: New Brunswick
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital Toronto
state: Ontario
city: Paris
country: France
facility: Hôpital Ambroise Paré
state: Boulogne-Billancourt
city: Nice
country: France
facility: Hôpital Pasteur 2
state: Provence-Alpes-Côte d'Azur
city: Montpellier
country: France
facility: Clinique Saint-Jean - Montpellier
city: Paris
country: France
facility: Bichat Hospital
city: Trappes
country: France
facility: Hôpital Privé de l'Ouest Parisien
state: Île-de-France
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
city: Zurich
country: Switzerland
facility: Schulthess Klinik
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: Lancashire
city: Wythenshawe
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust
state: Manchester
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: Merseyside
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middlesex
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
state: Nottinghamshire
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
state: Warwickshire
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Foundation Trust
state: West Midlands
city: Bristol
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Chris Peach, MBBS MD FRCS (Tr&Orth)
role: PRINCIPAL_INVESTIGATOR
References: