REGENETEN™ Bioinductive Implant System in Full-thickness Tears

Smith & Nephew, Inc.119 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Rotator Cuff Injuries

Interventions

Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentationDEVICE

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.

Arthroscopic rotator cuff repairPROCEDURE

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

Retear Rate at 6 Months

Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).

Time frame: 6 months

Secondary Outcomes

Number of Retears at 3 Months, 12 Months, and 24 Months

Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).

Time frame: 3 months, 12 months, and 24 months

Oxford Shoulder Score (OSS)

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.

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index

The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.

Harbin Clinic

Rome, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Sinai Hospital

Baltimore, Maryland, United States

Syracuse Orthopedic Specialists

DeWitt, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Houston Methodist The Woodlands

The Woodlands, Texas, United States

Ashland Memorial Medical Center

Ashland, Wisconsin, United States

Macquarie University Hospital

Sydney, New South Wales, Australia

OrthoSport Victoria

Richmond, Victoria, Australia

...and 20 more locations

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

Constant-Murley Score

The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

Subjective Shoulder Value (SSV)

The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score

The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for 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 participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score

The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: Medical Care

The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.

Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain

The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor

Time frame: 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities

The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor

Time frame: 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities

The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor

Time frame: 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations

The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor

Time frame: 3 months, 6 months, 12 months and 24 months

Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint

The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not

Time frame: 3 months, 6 months, 12 months and 24 months

Pain - Visual Analog Scale (VAS) Score

Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).

Time frame: 2 weeks, 6 weeks, 3 months and 6 months

MRI Tendon Findings: Supraspinatus Sugaya Score

The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.

Time frame: 3 months, 6 months, 12 months and 24 months

MRI Tendon Findings: Infraspinatus Sugaya Score

The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.

Time frame: 3 months, 6 months, 12 months and 24 months

MRI Tendon Findings: Supraspinatus Goutallier Classification

Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess

Time frame: 3 months, 6 months, 12 months and 24 months

MRI Tendon Findings: Infraspinatus Goutallier Classification

Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess

Time frame: 3 months, 6 months, 12 months and 24 months

Total Tendon Thickness

Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).

Time frame: 3 months, 6 months, 12 months and 24 months

Total Tendon Length

Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).

Time frame: 3 months, 6 months, 12 months and 24 months

Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])

Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).

Time frame: Day 0, 3 months and 6 months

Size of Retear: Anteroposterior (AP) Length

Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).

Time frame: Day 0, 3 months and 6 months

Size of Retear: Mediolateral (ML) Length

Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).

Time frame: Day 0, 3 months and 6 months

Shape of Retear: Operative Visit

Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine

Time frame: Day 0

Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months

Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine

Time frame: 3 months, 6 months, 12 months and 24 months

Return to Work Questionnaire

Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?

Time frame: 2 weeks, 6 weeks, 3 months and 6 months

Return to Work Questionnaire: Reason for Not Getting Back to Work

The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other

Time frame: 2 weeks, 6 weeks, 3 months, 6 months

Return to Work Questionnaire: Reason Couldn't Return to Activities

The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other

Time frame: 2 weeks, 6 weeks, 3 months, 6 months

Return to Work Questionnaire: Time Off

Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.

Time frame: 2 weeks, 6 weeks, 3 months, 6 months

Return to Work Questionnaire: Duration Away From Work (Days)

Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work

Time frame: 2 weeks, 6 weeks, 3 months, 6 months

Duration of Opioid Use

Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.

Time frame: Following surgery, up to 14 days

Opioid Use for More Than 5 Days Post-Surgery

Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.

Time frame: Following surgery, up to 14 days

Total Operative Time

Total operative time in minutes.

Time frame: Intraoperative

Sling Type

The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing

Time frame: up to 3 months

Mobilization Time in Sling

Mobilization time was the duration, measured in weeks, that participants spent in a sling.

Time frame: up to 3 months