Treatment of Partial-Thickness Rotator Cuff Tears

Not Applicable

Terminated

Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness

Interventions: Device: Arthroscopic repair of the high-grade (>50%) partialthickness
Device: REGENETEN™ Bioinductive Implant

Registration Number: NCT03734536

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

Detailed Description: The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (\>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 168

Inclusion Criteria

Patients will be considered qualified for enrollment if they meet the following criteria:

Male or female ≥18 years
High-grade (>50% tendon thickness) partial-thickness tear
Failed conservative medical management of the tendon tear defined as:
1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
2. Activity modification
3. Shoulder injection at the discretion of the surgeon
Able to comply with the post-operative physiotherapy and follow-up schedule
Able to speak and read English Provide written informed consent

Exclusion Criteria

Any one (1) of the following criteria will disqualify a patient from participation in the study:

Prior shoulder surgery on index shoulder within 12 months of enrollment
Failed primary rotator cuff surgery of the index shoulder
On steroids within 1 month of enrollment
Metastatic disease
Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
Concomitant biceps tenodesis
Rheumatoid arthritis
Advanced osteoarthritis
Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
Chronic pain disorders (i.e., fibromyalgia)
History of insulin dependent diabetes
History of heavy smoking (> 1 pack per day) within 6 months of enrollment
Currently involved in any injury litigation or workers compensation claims
Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic repair of the high-grade (>50%) partialthickness	Arthroscopic repair of the high-grade (>50%) partialthickness	Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
REGENETEN™ Bioinductive Implant	REGENETEN™ Bioinductive Implant	Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Score	Baseline and 3 months	American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery	Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12	American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12	Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12	Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	Baseline, 6 months, 12 months, 18 months and 24 months	American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	Baseline, 6 months, 12 months, 18 months and 24 months	Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	Baseline, 6 months, 12 months, 18 months and 24 months	Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months	Baseline, 3 months, 6 months, 12 months, and 24 months	Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function \& lower scores indicating worse shoulder function.
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery	Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12	Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery	Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12	Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months	Directly after surgery, 6 months, and 12 months	Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months	Directly after surgery, 6 months, and 12 months	Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Duration of Shoulder Immobilization	Following index surgery, up to 7 weeks	Duration of shoulder immobilization measured as days spent in a sling
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery	Up to 12 months	Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as "Not currently employed", "Did not return to work", "Returned to partial, modified, or parttime employment", or "Returned to fulltime employment." The type of work for each work status (excluding "Not currently employed") was then categorized as: * Very heavy work * Heavy work * Medium work * Light work * Sedentary work
Time to Return to Driving	Following index surgery, up to 139 days	Time to return to driving post-index surgery measured in days.
Time to Return to Sports	Following index surgery, approximately 1 year	Time to return to sports involving overhead throwing post-index surgery measured in days.
Number of Participants With Progression to Full-Thickness Tear at 12 Months	12 months	The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Number of Participants With Progression to Full-Thickness Tear at 24 Months	24 months	The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Number of Participants Percent Filling of Rotator Cuff at 12 Months	12 months	The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Number of Participants Percent Filling of Rotator Cuff at 24 Months	24 months	The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Rotator Cuff Tendon Thickness at 12 Months	12 Months	Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Rotator Cuff Tendon Thickness at 24 Months	24 Months	Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months	12 months	The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months	24 months	The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Number of Participants Sugaya Score of Rotator Cuff at 12 Months	12 months	The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Number of Participants Sugaya Score of Rotator Cuff at 24 Months	24 months	The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Number of Participants With Revision Surgery	Following index surgery, up to 24 months	Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery.
Aggregate Health Care Utilization Costs	Following index surgery, up to 12 months	Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records.
Operating Room Time (Index Surgery)	Intra-operative	Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes.
Number of Steroid Injections	Following index surgery, up to 12 months	The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record.
Number of Unscheduled Clinic Visits	Following index surgery, up to 12 months	The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record.
Number of For-Cause Imaging Procedures	Following index surgery, up to 12 months	The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record
Number of Physiotherapy Sessions	Following index surgery, up to 12 months	The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record

Trial Locations

Locations (10): University of Florida Orthopaedics and Sports Medicine
🇺🇸
Gainesville, Florida, United States
Anne Arundel Medical Center/Luminis Health
🇺🇸
Annapolis, Maryland, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Baptist Health
🇺🇸
Jacksonville Beach, Florida, United States
Harbin Clinic
🇺🇸
Rome, Georgia, United States
Ochsner Health Center
🇺🇸
New Orleans, Louisiana, United States
Columbia University
🇺🇸
New York, New York, United States
Syracuse Orthopedic Specialist
🇺🇸
DeWitt, New York, United States
Orthopedic Associates of SW Ohio
🇺🇸
Centerville, Ohio, United States
Texas Orthopedic Specialists
🇺🇸
Bedford, Texas, United States