Arthroscopic Surgical Treatment of High-grade (>50%) PartialthicknessREGEN PUB 2018NCT03734536

Treatment of Partial-Thickness Rotator Cuff Tears

A study testing REGENETEN™ Bioinductive Implant and Arthroscopic repair of the high-grade (>50%) partial-thickness in people with Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness, run by Smith & Nephew, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
What is being tested?: REGENETEN™ Bioinductive Implant and Arthroscopic repair of the high-grade (>50%) partial-thickness
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 10 sitesUnited States
Study dates: 5 Dec 2018to 11 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
Four (4) to six (6) weeks of formal physical therapy or guided home exercises
Activity modification

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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

Who cannot join

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)

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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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Anne Arundel Medical Center/Luminis Health
Annapolis, Maryland, 21401
Texas Orthopedic Specialists
Bedford, Texas, 76021
Orthopedic Associates of SW Ohio
Centerville, Ohio, 45459
Syracuse Orthopedic Specialist
DeWitt, New York, 13214
University of Florida Orthopaedics and Sports Medicine
Gainesville, Florida, 32607
Baptist Health
Jacksonville Beach, Florida, 32250
University of Kentucky
Lexington, Kentucky, 40506
Ochsner Health Center
New Orleans, Louisiana, 70121
Columbia University
New York, New York, 10032
Harbin Clinic
Rome, Georgia, 30165

Other trials in United States

About this study

Official title: Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

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.

Read the 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.

Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Being tested: REGENETEN™ Bioinductive Implant, Arthroscopic repair of the high-grade (>50%) partial-thickness
Keywords: REGENETEN, REGENETEN Bioinductive Implant, highgrade partial thickness tear, rotator cuff tear, rotator cuff repair
Medical subject headings: Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03734536
Study group	Role	What they receive
REGENETEN™ Bioinductive Implant	Other	Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. Receives: Device: REGENETEN™ Bioinductive Implant
Arthroscopic repair of the high-grade (>50%) partial-thickness	Other	Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Receives: Device: Arthroscopic repair of the high-grade (>50%) partial-thickness

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 3 months

Secondary outcomes (32)

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.
Measured: 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)?''
Measured: 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).
Measured: 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.
Measured: 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)?''
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Directly after surgery, 6 months, and 12 months
Duration of Shoulder Immobilization
Duration of shoulder immobilization measured as days spent in a sling
Measured: 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
Measured: Up to 12 months
Time to Return to Driving
Time to return to driving post-index surgery measured in days.
Measured: 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.
Measured: 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
Measured: 12 months
Number of Participants With Progression to Full-Thickness Tear at 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
Measured: 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%
Measured: 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%
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Following index surgery, up to 12 months
Operating Room Time (Index Surgery)
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.
Measured: Intra-operative
Number of Steroid Injections
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.
Measured: Following index surgery, up to 12 months
Number of Unscheduled Clinic Visits
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.
Measured: Following index surgery, up to 12 months
Number of For-Cause Imaging Procedures
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
Measured: Following index surgery, up to 12 months
Number of Physiotherapy Sessions
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
Measured: Following index surgery, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201811 Sep 2023

First posted8 Nov 2018
Study start5 Dec 2018
Primary completion11 Sep 2023
Study completion11 Sep 2023

Why it stopped: Business reasons not related to patient safety

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroscopic Surgical Treatment of High-grade (>50%) PartialthicknessStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03734536
Sponsor's protocol ID: REGEN.PUB.2018.09
Acronym: REGEN PUB 2018
Status last verified: Oct 2023
First submitted: 6 Nov 2018
Last updated: 19 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears
ClinicalTrials.gov ID: NCT03734536
Acronym / sponsor ID: REGEN PUB 2018 / REGEN.PUB.2018.09
Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Keywords: REGENETEN, REGENETEN Bioinductive Implant, highgrade partial thickness tear, rotator cuff tear, rotator cuff repair
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business reasons not related to patient safety
Enrolment: 168 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Collaborators: Global Research Solutions, Medical Metrics Diagnostics, Inc
Study start: 5 Dec 2018 (actual)
Primary completion: 11 Sep 2023 (actual)
Study completion: 11 Sep 2023 (actual)
First posted: 8 Nov 2018 (actual)
Results: Posted 19 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
REGENETEN™ Bioinductive Implant	Other	Device: REGENETEN™ Bioinductive ImplantSurgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Arthroscopic repair of the high-grade (>50%) partial-thickness	Other	Device: Arthroscopic repair of the high-grade (>50%) partial-thicknessSurgical treatment of partial-thickness rotator cuff tears using standard techniques.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female ≥18 years
High-grade (>50% tendon thickness) partial-thickness tear
Failed conservative medical management of the tendon tear defined as:
Able to comply with the post-operative physiotherapy and follow-up schedule
Able to speak and read English Provide written informed consent

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REGENETEN™ Bioinductive ImplantThe REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Device	REGENETEN™ Bioinductive Implant
Arthroscopic repair of the high-grade (>50%) partial-thicknessSurgical treatment of partial-thickness rotator cuff tears using standard techniques.	Device	Arthroscopic repair of the high-grade (>50%) partial-thickness

Primary outcome

American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 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.

32 secondary outcomes

American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
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
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
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
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
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
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
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
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
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
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
Time frame: Directly after surgery, 6 months, and 12 months
Duration of Shoulder Immobilization
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
Time frame: Up to 12 months
Time to Return to Driving
Time frame: Following index surgery, up to 139 days
Time to Return to Sports
Time frame: Following index surgery, approximately 1 year
Number of Participants With Progression to Full-Thickness Tear at 12 Months
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
Time frame: 12 months
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Time frame: 24 months
Rotator Cuff Tendon Thickness at 12 Months
Time frame: 12 Months
Rotator Cuff Tendon Thickness at 24 Months
Time frame: 24 Months
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Time frame: 12 months
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Time frame: 24 months
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Time frame: 12 months
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Time frame: 24 months
Number of Participants With Revision Surgery
Time frame: Following index surgery, up to 24 months
Aggregate Health Care Utilization Costs
Time frame: Following index surgery, up to 12 months
Operating Room Time (Index Surgery)
Time frame: Intra-operative
Number of Steroid Injections
Time frame: Following index surgery, up to 12 months
Number of Unscheduled Clinic Visits
Time frame: Following index surgery, up to 12 months
Number of For-Cause Imaging Procedures
Time frame: Following index surgery, up to 12 months
Number of Physiotherapy Sessions
Time frame: Following index surgery, up to 12 months

Results and safety

Results posted to the registry on 19 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REGENETEN™ Bioinductive Implant	59	48
Arthroscopic Repair of the High-grade (>50%) Partial-thickness	59	47

Primary outcome: American Shoulder and Elbow Surgeons (ASES) Score

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	REGENETEN™ Bioinductive Implant n = 58	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n = 56
Baseline	59.46 (17.07)	52.10 (15.61)
3 months	80.07 (13.30)	74.61 (12.35)

Population analysed: Overall number of participants with available data for each treatment at the time frame indicated

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected upon implantation of device through study termination, up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REGENETEN™ Bioinductive Implant	33 of 59 (55.9%)	51 of 59 (86.4%)	0 of 59
Arthroscopic Repair of the High-grade (>50%) Partial-thickness	17 of 59 (28.8%)	56 of 59 (94.9%)	0 of 59

Limitations and caveats (from the sponsor): 1. Study terminated due to patient selection bias (age, tear severity). 2. Low patient diary completion compliance (pain medication, for-cause imaging). 3. Unreliable MRI data (ex: tendon fill-in, tendon differentiation, tendon thickness) provided by independent reviewer.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Howard Harris principal investigator

Texas Orthopedic Specialists

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American Shoulder and Elbow Surgeons (ASES) Score (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03734536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.