Arthroplasty, Replacement, ShoulderNCT04861714
Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
A study testing Regeneten and Standard repair in people with Arthroplasty, Replacement, Shoulder, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- Regeneten and Standard repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients healthy enough to undergo primary anatomic TSA
- Being treated with subscapularis tenotomy or subscapularis peel.
- Age 50 or above
- Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).
Who cannot join
- Revision arthroplasty
- Reverse arthroplasty
- Requiring a lesser tuberosity osteotomy
- Intraoperative identification of rotator cuff tear requiring repair
- Object to using cow derived material
- Prior index shoulder surgery requiring treatment to the subscapularis
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Sports Medicine Center
Columbus, Ohio, 43221
About this study
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.
Read the detailed description
Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Being tested
- Regeneten, Standard repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegenetenDevice
Augmentation of standard subscapularis repair with regeneten patch
Standard repairProcedure or surgery
Standard subscapularis repair
| Study group | Role | What they receive |
|---|---|---|
| Regeneten | Active comparator | Standard subscapularis repair with Regeneten augmentation group Receives: Device: Regeneten |
| Standard repair | Other | Standard subscapularis repair Receives: Procedure: Standard repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subscapularis repair integrity assessed by lift-off test using dynamometry.
Pounds (lbs) of force that the subject can produce during the lift off test will be recorded.
Measured: 12 months post-op
Secondary outcomes (32)
Forward elevation active range of motion as assessed by treating physician
The amount of forward elevation range of motion will be reported in degrees from 0-180.
Measured: 6 weeks
Forward elevation active range of motion as assessed by treating physician
The amount of forward elevation range of motion will be reported in degrees from 0-180.
Measured: 3 months
Forward elevation active range of motion as assessed by treating physician
The amount of forward elevation range of motion will be reported in degrees from 0-180.
Measured: 6 months
Forward elevation active range of motion as assessed by treating physician
The amount of forward elevation range of motion will be reported in degrees from 0-180.
Measured: 12 months
Abduction active range of motion as assessed by treating physician
The amount of abduction range of motion will be reported in degrees from 0-180.
Measured: 6 weeks
Abduction active range of motion as assessed by treating physician
The amount of abduction range of motion will be reported in degrees from 0-180.
Measured: 3 months
Abduction active range of motion as assessed by treating physician
The amount of abduction range of motion will be reported in degrees from 0-180.
Measured: 6 months
Abduction active range of motion as assessed by treating physician
The amount of abduction range of motion will be reported in degrees from 0-180.
Measured: 12 months
External rotation active range of motion as assessed by treating physician
The amount of external rotation range of motion will be reported in degrees from 0-180.
Measured: 6 weeks
External rotation active range of motion as assessed by treating physician
The amount of external rotation range of motion will be reported in degrees from 0-180.
Measured: 3 months
External rotation active range of motion as assessed by treating physician
The amount of external rotation range of motion will be reported in degrees from 0-180.
Measured: 6 months
External rotation active range of motion as assessed by treating physician
The amount of external rotation range of motion will be reported in degrees from 0-180.
Measured: 12 months
Internal rotation active range of motion as assessed by treating physician
The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.
Measured: 6 weeks
Internal rotation active range of motion as assessed by treating physician
The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.
Measured: 3 months
Internal rotation active range of motion as assessed by treating physician
The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.
Measured: 6 months
Internal rotation active range of motion as assessed by treating physician
The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.
Measured: 12 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 6 weeks
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 3 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 6 months
Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)
The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 12 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.
Measured: 6 weeks
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.
Measured: 3 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.
Measured: 6 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.
Measured: 12 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.
Measured: 6 weeks
Patient reported clinical outcome scores- Simple shoulder test (SST)
The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.
Measured: 3 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.
Measured: 6 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.
Measured: 12 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 6 weeks
Patient reported clinical outcome scores- Simple shoulder value (SST)
The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 3 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 6 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start14 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, ShoulderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Gregory Cvetanovich, Ohio State University
- Investigators
- Gregory Cvetanovich, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861714
- Sponsor's protocol ID
- 2019H0419
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2021
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
- ClinicalTrials.gov ID
- NCT04861714
- Acronym / sponsor ID
- 2019H0419
- Conditions
- Arthroplasty, Replacement, Shoulder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.
Detailed description
Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regeneten | Active comparator | Device: RegenetenStandard subscapularis repair with Regeneten augmentation group |
| Standard repair | Other | Procedure: Standard repairStandard subscapularis repair |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients healthy enough to undergo primary anatomic TSA
- Being treated with subscapularis tenotomy or subscapularis peel.
- Age 50 or above
- Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).
Key exclusion criteria (6 listed)
- Revision arthroplasty
- Reverse arthroplasty
- Requiring a lesser tuberosity osteotomy
- Intraoperative identification of rotator cuff tear requiring repair
- Object to using cow derived material
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 |
|---|---|---|
| RegenetenAugmentation of standard subscapularis repair with regeneten patch | Device | Regeneten |
| Standard repairStandard subscapularis repair | Procedure or surgery | Standard repair |
Primary outcome
Subscapularis repair integrity assessed by lift-off test using dynamometry.
Time frame: 12 months post-op
Pounds (lbs) of force that the subject can produce during the lift off test will be recorded.
32 secondary outcomes
Forward elevation active range of motion as assessed by treating physician
Time frame: 6 weeks
Forward elevation active range of motion as assessed by treating physician
Time frame: 3 months
Forward elevation active range of motion as assessed by treating physician
Time frame: 6 months
Forward elevation active range of motion as assessed by treating physician
Time frame: 12 months
Abduction active range of motion as assessed by treating physician
Time frame: 6 weeks
Abduction active range of motion as assessed by treating physician
Time frame: 3 months
Abduction active range of motion as assessed by treating physician
Time frame: 6 months
Abduction active range of motion as assessed by treating physician
Time frame: 12 months
External rotation active range of motion as assessed by treating physician
Time frame: 6 weeks
External rotation active range of motion as assessed by treating physician
Time frame: 3 months
External rotation active range of motion as assessed by treating physician
Time frame: 6 months
External rotation active range of motion as assessed by treating physician
Time frame: 12 months
Internal rotation active range of motion as assessed by treating physician
Time frame: 6 weeks
Internal rotation active range of motion as assessed by treating physician
Time frame: 3 months
Internal rotation active range of motion as assessed by treating physician
Time frame: 6 months
Internal rotation active range of motion as assessed by treating physician
Time frame: 12 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
Time frame: 6 weeks
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
Time frame: 3 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
Time frame: 6 months
Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)
Time frame: 12 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
Time frame: 6 weeks
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
Time frame: 3 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
Time frame: 6 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
Time frame: 12 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
Time frame: 6 weeks
Patient reported clinical outcome scores- Simple shoulder test (SST)
Time frame: 3 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
Time frame: 6 months
Patient reported clinical outcome scores- Simple shoulder test (SST)
Time frame: 12 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
Time frame: 6 weeks
Patient reported clinical outcome scores- Simple shoulder value (SST)
Time frame: 3 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
Time frame: 6 months
Patient reported clinical outcome scores- Simple shoulder value (SST)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Gregory Cvetanovich, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regeneten and Standard repair in people with Arthroplasty, Replacement, Shoulder, run by Ohio State University at 1 site in United States.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Subscapularis repair integrity assessed by lift-off test using dynamometry. (time frame: 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.