Treatment of Partial-Thickness Rotator Cuff Tears

Smith & Nephew, Inc.168 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

168

Conditions

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

Interventions

REGENETEN™ Bioinductive ImplantDEVICE

The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.

Arthroscopic repair of the high-grade (>50%) partial-thicknessDEVICE

Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients will be considered qualified for enrollment if they meet the following criteria: 1. Male or female ≥18 years 2. High-grade (\>50% tendon thickness) partial-thickness tear 3. 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 4. Able to comply with the post-operative physiotherapy and follow-up schedule 5. 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: 1. Prior shoulder surgery on index shoulder within 12 months of enrollment 2. Failed primary rotator cuff surgery of the index shoulder 3. On steroids within 1 month of enrollment 4. Metastatic disease 5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP) 6. Concomitant biceps tenodesis 7. Rheumatoid arthritis 8. Advanced osteoarthritis 9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 10. Chronic pain disorders (i.e., fibromyalgia) 11. History of insulin dependent diabetes 12. History of heavy smoking (\> 1 pack per day) within 6 months of enrollment 13. Currently involved in any injury litigation or workers compensation claims 14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Locations (10)

University of Florida Orthopaedics and Sports Medicine

Gainesville, Florida, United States

Baptist Health

Jacksonville Beach, Florida, United States

Harbin Clinic

Rome, Georgia, United States

Outcomes

Primary Outcomes

American Shoulder and Elbow Surgeons (ASES) Score

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.

Time frame: Baseline and 3 months

Secondary Outcomes

American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery

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.

Time frame: 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 Value (SANE) Score Weekly Through 3 Months Post-Index Surgery

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)?''

Time frame: 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 Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery

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).

Data from ClinicalTrials.gov

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University of Kentucky

Lexington, Kentucky, United States

Ochsner Health Center

New Orleans, Louisiana, United States

Anne Arundel Medical Center/Luminis Health

Annapolis, Maryland, United States

Syracuse Orthopedic Specialist

DeWitt, New York, United States

Columbia University

New York, New York, United States

Orthopedic Associates of SW Ohio

Centerville, Ohio, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Time frame: 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, 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.

Time frame: Baseline, 6 months, 12 months, 18 months and 24 months

Single Assessment Numeric Value (SANE) Score at 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)?''

Time frame: Baseline, 6 months, 12 months, 18 months and 24 months

American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at 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).

Time frame: Baseline, 6 months, 12 months, 18 months and 24 months

Constant-Murley Score at 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.

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

Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery

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.

Time frame: 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

Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery

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.

Time frame: 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 Use to Treat the Index Shoulder 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.

Time frame: Directly after surgery, 6 months, and 12 months

Non-Opioid Prescription Medication Use to Treat the Index Shoulder 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.

Time frame: Directly after surgery, 6 months, and 12 months

Duration of Shoulder Immobilization

Duration of shoulder immobilization measured as days spent in a sling

Time frame: Following index surgery, up to 7 weeks

Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery

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 frame: Up to 12 months

Time to Return to Driving

Time to return to driving post-index surgery measured in days.

Time frame: Following index surgery, up to 139 days

Time to Return to Sports

Time to return to sports involving overhead throwing post-index surgery measured in days.

Time frame: Following index surgery, approximately 1 year

Number of Participants With Progression to Full-Thickness Tear at 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

Time frame: 12 months

Number of Participants With Progression to Full-Thickness Tear at 24 Months

Time frame: 24 months

Number of Participants Percent Filling of Rotator Cuff at 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%

Time frame: 12 months

Number of Participants Percent Filling of Rotator Cuff at 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%

Time frame: 24 months

Rotator Cuff Tendon Thickness at 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)

Time frame: 12 Months

Rotator Cuff Tendon Thickness at 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)

Time frame: 24 Months

Number of Participants Goutallier Classification of Rotator Cuff at 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

Time frame: 12 months

Number of Participants Goutallier Classification of Rotator Cuff at 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

Time frame: 24 months

Number of Participants Sugaya Score of Rotator Cuff at 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

Time frame: 12 months

Number of Participants Sugaya Score of Rotator Cuff at 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

Time frame: 24 months

Number of Participants With Revision Surgery

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.

Time frame: Following index surgery, up to 24 months

Aggregate Health Care Utilization Costs

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.