Clinical trial NCT05444465: Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Official title: Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Rotator cuff tear
High grade partial thickness tears
REGENETEN Bioinductive Implant System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Detailed description: The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).

Eligibility criteria: Inclusion Criteria:

* The subject must provide written informed consent.
* Subject is \> eighteen (18) years of age (no upper limit).
* Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
* Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
* Subject willing and able to make all required study visits.
* Subject able to follow instructions and deemed capable of completing all study questionnaires.

Exclusion Criteria:

* Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
* Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
* Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
* Subjects with current or prior infection of the ipsilateral shoulder.
* Subjects with known hypersensitivity to bovine-derived materials.
* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
* Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
* Subjects with a planned surgery on the contra-lateral shoulder within the study period.
* Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
* Subjects with a full thickness rotator cuff tear.
* Subjects with a subscapularis tear requiring repair.
* Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
* Subjects requiring a concomitant os acromiale fixation procedure.
* Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
* Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair 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.
* Subjects with neurologic conditions effecting either upper extremity.
* Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
* Subjects who are pregnant or breast feeding.
* Subjects who are currently involved in any injury litigation relating to the index shoulder.
* Subjects with current workers compensation claim.
* Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
* Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
* 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.
* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
* Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Primary outcomes:
measure: Change in Western Ontario Rotator Cuff (WORC)
timeFrame: Change from baseline to 3 months post-intervention
Secondary outcomes:
measure: Western Ontario Rotator Cuff (WORC)
timeFrame: Pre-op, 6 weeks, 3, 6, 12 and 24 months
measure: Constant-Murley Score
timeFrame: Pre-Op, 3, 6, 12 and 24 months
measure: Subjective Shoulder Value (SSV) score
timeFrame: Pre-Op, 6 weeks, 3, 12 and 24 months
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
timeFrame: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
measure: Change in Western Ontario Rotator Cuff (WORC)
timeFrame: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
measure: Change in Constant-Murley Score
timeFrame: Change from Pre-Op to 6 weeks, 3, 12 and 24 months
measure: Change in Subjective Shoulder Value (SSV) score
timeFrame: Change from Pre-Op to 6 weeks, 3, 12 and 24 months
measure: Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
timeFrame: Pre-Op, 3, 6, 12 and 24 months
measure: Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
timeFrame: Pre-op, 6 weeks, 3, 6, 12 and 24 months
measure: Percent Achieving MCID for Subjective Shoulder Value (SSV) score
timeFrame: Pre-Op, 6 weeks, 3, 12 and 24 months
measure: Patient Satisfaction
timeFrame: 6 weeks, 3, 6, 12 and 24 months
measure: Pain, Visual analog scale (VAS) Score
timeFrame: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
measure: MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
timeFrame: 12 months
measure: MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
timeFrame: 12 months
measure: MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
timeFrame: 12 months
measure: MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
timeFrame: 12 months
measure: MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
timeFrame: 12 months
measure: Incidence of Revision Surgery
timeFrame: 1, 3 and 6 weeks, 3, 6, 12 and 24 months
measure: Time to return to work
timeFrame: Up to 24 months
measure: Time to return to driving
timeFrame: Up to 24 months
measure: Time to return to sports
timeFrame: Up to 24 months
measure: Total operative time
timeFrame: Inter-operative time
measure: Physical Therapy Utilization
timeFrame: Up to 24 months
measure: Cumulative days of opioid use
timeFrame: Day 1-14
measure: Duration of shoulder immobilization following index surgery
timeFrame: 1, 3 and 6 weeks, 3 months
Other outcomes:
Locations:
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Rockford
country: United States
facility: OrthoIllinois LTD
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital Baltimore
state: Maryland
city: Garfield Heights
country: United States
facility: Cleveland Clinic - Sports Health
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
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: Memorial Medical Center
state: Wisconsin
city: Richmond
country: Australia
facility: OrthoSport Victoria
state: Victoria
city: Calgary
country: Canada
facility: Access Orthopaedics
state: Alberta
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: Research St. Joseph's
state: Ontario
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi,
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Chertsey
country: United Kingdom
facility: Ashford & St Peter's Hospitals NHS Foundation Trust
state: Surrey
city: Bath
country: United Kingdom
facility: Sulis Hospital
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust
Study officials:
affiliation: Smith & Nephew, Inc.
name: Laura Mills
role: STUDY_CHAIR
References: