Shoulder InjuriesNCT05487677
Subscapularis Repair Augmentation for Total Shoulder Arthroplasty
A study testing BioBrace Augmentation and Standard Repair with Sutures in people with Shoulder Injuries, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries
- What is being tested?
- BioBrace Augmentation and Standard Repair with Sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total Shoulder Arthroplasty
Who cannot join
- Vulnerable population
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Redwood City, California, 94063
Jessica Nguyen, 650-725-0003, jessn16@@stanford.edu
Michael Freehill, MD
About this study
Official title: Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty
The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.
Read the detailed description
The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.
- Conditions
- Shoulder Injuries
- Being tested
- BioBrace Augmentation, Standard Repair with Sutures
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBrace AugmentationDevice
Also called Implant Group
During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.
Standard Repair with SuturesProcedure or surgery
Also called Stitch Group
During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| BioBrace Augmentation | Experimental | During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair. Receives: Device: BioBrace Augmentation |
| Standard Repair with Sutures | Active comparator | During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures. Receives: Procedure: Standard Repair with Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in continuity of subscapularis tissue on ultrasound
Continuity of subscapularis tissue on ultrasound
Measured: 6 weeks, 6 months after surgery
Difference in thickness of the subscapularis tissue on ultrasound
Thickness of subscapularis tissue on ultrasound
Measured: 3 months, 1 years after surgery
Evaluate arthritis on shoulder x-ray
Amount of arthritis or wear patterns on shoulder x-Ray
Measured: Surgery
Difference in signs of loosening or wear patterns in shoulder X-Ray
Signs of loosening or wear patterns on shoulder x-ray
Measured: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Secondary outcomes (3)
American Shoulder & Elbow Surgeons Score (ASES) score
is a 100-point scale that consists of two dimensions: pain and activities of daily living. 0 indicates worse shoulder condition and 100 indicates best shoulder condition. The greater the score, the lower the level of shoulder disability
Measured: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Passive Range of Motion
Examining passive range of motion - forward flexion, external rotation, abduction
Measured: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Active Range of Motion
Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press
Measured: 3 months, 6 months, 1 year, 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Dec 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Model description
- Patients undergoing reverse shoulder arthroplasty will be recruited, consented, \& enrolled. Patient will be randomized to standard repair with sutures versus standard repair with BioBrace augmentation of the repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael T. Freehill, Stanford University
- Investigators
- Michael T Freehill, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487677
- Sponsor's protocol ID
- 64618
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05487677
- Acronym / sponsor ID
- 64618
- Conditions
- Shoulder Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 4 Aug 2022 (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 primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.
Detailed description
The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing reverse shoulder arthroplasty will be recruited, consented, \& enrolled. Patient will be randomized to standard repair with sutures versus standard repair with BioBrace augmentation of the repair.
| Arm | Type | Receives |
|---|---|---|
| BioBrace Augmentation | Experimental | Device: BioBrace AugmentationDuring the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair. |
| Standard Repair with Sutures | Active comparator | Procedure: Standard Repair with SuturesDuring the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total Shoulder Arthroplasty
Key exclusion criteria (1 listed)
- Vulnerable population
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 |
|---|---|---|
| BioBrace AugmentationAlso: Implant GroupDuring shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material. | Device | BioBrace Augmentation |
| Standard Repair with SuturesAlso: Stitch GroupDuring shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment. | Procedure or surgery | Standard Repair with Sutures |
Primary outcome
Difference in continuity of subscapularis tissue on ultrasound
Time frame: 6 weeks, 6 months after surgery
Continuity of subscapularis tissue on ultrasound
Difference in thickness of the subscapularis tissue on ultrasound
Time frame: 3 months, 1 years after surgery
Thickness of subscapularis tissue on ultrasound
Evaluate arthritis on shoulder x-ray
Time frame: Surgery
Amount of arthritis or wear patterns on shoulder x-Ray
Difference in signs of loosening or wear patterns in shoulder X-Ray
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Signs of loosening or wear patterns on shoulder x-ray
3 secondary outcomes
American Shoulder & Elbow Surgeons Score (ASES) score
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Passive Range of Motion
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Active Range of Motion
Time frame: 3 months, 6 months, 1 year, 2 years after surgery
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 19 Aug 2026.
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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.
Michael T Freehill, MD principal investigator
Stanford 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 BioBrace Augmentation and Standard Repair with Sutures in people with Shoulder Injuries, run by Stanford 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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?
Contact Jessica Nguyen (650-725-0003, jessn16@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in continuity of subscapularis tissue on ultrasound (time frame: 6 weeks, 6 months after surgery). The study lists 4 primary outcomes in all. 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 19 Aug 2026.