Rotator Cuff InjuriesNCT04634084
Subacromial Bursa Re-Implantation After Rotator Cuff Repair
A study testing Experimental group(Bursa Implantation) in people with Rotator Cuff Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort… Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Experimental group(Bursa Implantation)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
- Are able to provide informed consent
- Can commit to study follow-up visits or procedures
Who cannot join
- Are unable to provide informed consent
- Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation
- Have active infection at operative site
- Have active systemic infection
- Chronic inflammatory condition such as rheumatoid arthritis or lupus
- Has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery
- Have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder.
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial
The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Experimental group(Bursa Implantation), Control Group(Standard of Care)
- Keywords
- subacromial bursa
- 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.
Experimental group(Bursa Implantation)Procedure or surgery
Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.In the experimental group, instead of being discarded, this minced bursal tissue will be collected via a sterile filtration device attached to the oscillating shaver. The bursal tissue is then placed into a sterile syringe, and reimplanted back onto the bursal surface of the rotator cuff repair at the completion of the case. The arthroscopic fluid is turned off, and fluid is evacuated from the shoulder prior to reimplantation of the bursa.. Nothing is added to the bursa prior to reimplantation. There are no reagents. The bursa tissue is purely the minced bursa tissue removed from the patient, and never leaves the sterile field.
Control Group(Standard of Care)Procedure or surgery
Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.The current standard of care procedure is to discard this tissue, and then proceed with the rotator cuff repair
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Procedure: Experimental group(Bursa Implantation) |
| Control Group | Active comparator | Not described Receives: Procedure: Control Group(Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion
range of motion will be measured using a goniometer
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Change in strength of shoulder
shoulder strength will be measured using handheld dynamometer
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
This is scored form 0-100,lower score means worse pain
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Change in pain as assessed by the Visual Analog Scale (VAS)
The VAS is scored form 0-10, 0 being no pain and 10 being worst pain
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)
PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function
Measured: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Secondary outcomes (4)
Number of participants with improvement in structural integrity as assessed by postoperative MRI
Measured: 6 months post surgery
Number of participants with improvement in structural integrity as assessed by postoperative MRI
Measured: 12 months post surgery
Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.
Measured: 6 months post surgery
Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start24 Mar 2021
- Primary completion30 Oct 2024
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James M. Gregory, The University of Texas Health Science Center, Houston
- Investigators
- James M Gregory, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634084
- Sponsor's protocol ID
- HSC-MS-19-1092
- Status last verified
- Jun 2025
- First submitted
- 16 Nov 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gregory JM, Smith AZ, Zandiyeh P. Effect of Subacromial Bursa Augmentation on Self-Reported and Magnetic Resonance Imaging Outcomes in Arthroscopic Rotator Cuff Repair: A Prospective, Blinded Randomized Clinical Trial. Am J Sports Med. 2026 Mar;54(4):848-856. doi: 10.1177/03635465251407328. Epub 2026 Jan 18.
PubMed 41549447
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04634084
- Acronym / sponsor ID
- HSC-MS-19-1092
- Conditions
- Rotator Cuff Injuries
- Keywords
- subacromial bursa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 18 Nov 2020 (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 clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Experimental group(Bursa Implantation) |
| Control Group | Active comparator | Procedure: Control Group(Standard of Care) |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
- Are able to provide informed consent
- Can commit to study follow-up visits or procedures
Key exclusion criteria (8 listed)
- Are unable to provide informed consent
- Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation
- Have active infection at operative site
- Have active systemic infection
- Chronic inflammatory condition such as rheumatoid arthritis or lupus
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 |
|---|---|---|
| Experimental group(Bursa Implantation)Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.In the experimental group, instead of being discarded, this minced bursal tissue will be collected via a sterile filtration device attached to the oscillating shaver. The bursal tissue is then placed into a sterile syringe, and reimplanted back onto the bursal surface of the rotator cuff repair at the completion of the case. The arthroscopic fluid is turned off, and fluid is evacuated from the shoulder prior to reimplantation of the bursa.. Nothing is added to the bursa prior to reimplantation. There are no reagents. The bursa tissue is purely the minced bursa tissue removed from the patient, and never leaves the sterile field. | Procedure or surgery | Experimental group |
| Control Group(Standard of Care)Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.The current standard of care procedure is to discard this tissue, and then proceed with the rotator cuff repair | Procedure or surgery | Control Group |
Primary outcome
Change in range of motion
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
range of motion will be measured using a goniometer
Change in strength of shoulder
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
shoulder strength will be measured using handheld dynamometer
Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
This is scored form 0-100,lower score means worse pain
Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)
Change in pain as assessed by the Visual Analog Scale (VAS)
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
The VAS is scored form 0-10, 0 being no pain and 10 being worst pain
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)
Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function
4 secondary outcomes
Number of participants with improvement in structural integrity as assessed by postoperative MRI
Time frame: 6 months post surgery
Number of participants with improvement in structural integrity as assessed by postoperative MRI
Time frame: 12 months post surgery
Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.
Time frame: 6 months post surgery
Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.
Time frame: 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 41549447Gregory JM, Smith AZ, Zandiyeh P. Effect of Subacromial Bursa Augmentation on Self-Reported and Magnetic Resonance Imaging Outcomes in Arthroscopic Rotator Cuff Repair: A Prospective, Blinded Randomized Clinical Trial. Am J Sports Med. 2026 Mar;54(4):848-856. doi: 10.1177/03635465251407328. Epub 2026 Jan 18.
- Individual participant dataSharing planned: No
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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.
James M Gregory, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group(Bursa Implantation) in people with Rotator Cuff Injuries, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in range of motion (time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery). The study lists 6 primary outcomes in all. 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 NCT04634084, which also lists 1 linked publication.
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 17 Jun 2025.