Partial Thickness Rotator Cuff TearsNCT05823428
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
A study testing Augmentation with subacromial bursa + acromioplasty and Rotator cuff debridement + acromioplasty in people with Partial Thickness Rotator Cuff Tears, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Thickness Rotator Cuff Tears
- What is being tested?
- Augmentation with subacromial bursa + acromioplasty and Rotator cuff debridement + acromioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bursal side rotator cuff tears in MRI sections
- Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months
- 25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side
Who cannot join
- Previous surgery
- tears greater than 50% or 6 mm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Prof. Cemil Tascioglu City Hospital
Istanbul, 34040
About this study
The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.
- Conditions
- Partial Thickness Rotator Cuff Tears
- Being tested
- Augmentation with subacromial bursa + acromioplasty, Rotator cuff debridement + acromioplasty
- Keywords
- partial thickness, bursal side, rotator cuff, full thickness, subacromial bursa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentation with subacromial bursa + acromioplastyProcedure or surgery
Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B
Rotator cuff debridement + acromioplastyProcedure or surgery
Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff debridement + acromioplasty | Active comparator | Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients. Receives: Procedure: Rotator cuff debridement + acromioplasty |
| Augmentation with subacromial bursa + acromioplasty | Active comparator | Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients. Receives: Procedure: Augmentation with subacromial bursa + acromioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI.
Our Primary Outcome Measure is to investigate the effects of biological augmentation with subacromial bursa in arthroscopic bursal-sided partial thickness rotator cuff repair with postoperative MRI and functional scores with Constant-Murley and Ases scores.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823428
- Sponsor's protocol ID
- Subacromial bursa Augmentation
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05823428
- Acronym / sponsor ID
- Subacromial bursa Augmentation
- Conditions
- Partial Thickness Rotator Cuff Tears
- Keywords
- partial thickness, bursal side, rotator cuff, full thickness, subacromial bursa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 21 Apr 2023 (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 investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff debridement + acromioplasty | Active comparator | Procedure: Rotator cuff debridement + acromioplastyGroup A was formed by performing rotator cuff debridement + acromioplasty in 18 patients. |
| Augmentation with subacromial bursa + acromioplasty | Active comparator | Procedure: Augmentation with subacromial bursa + acromioplastyGroup B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bursal side rotator cuff tears in MRI sections
- Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months
- 25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side
Key exclusion criteria (2 listed)
- Previous surgery
- tears greater than 50% or 6 mm
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 |
|---|---|---|
| Augmentation with subacromial bursa + acromioplastyTwo intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B | Procedure or surgery | Augmentation with subacromial bursa + acromioplasty |
| Rotator cuff debridement + acromioplastyTwo intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B | Procedure or surgery | Rotator cuff debridement + acromioplasty |
Primary outcome
Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI.
Time frame: 18 months
Our Primary Outcome Measure is to investigate the effects of biological augmentation with subacromial bursa in arthroscopic bursal-sided partial thickness rotator cuff repair with postoperative MRI and functional scores with Constant-Murley and Ases scores.
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 21 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentation with subacromial bursa + acromioplasty and Rotator cuff debridement + acromioplasty in people with Partial Thickness Rotator Cuff Tears, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 2 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 21 Apr 2023. 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 Turkey (Türkiye). 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?
Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI. (time frame: 18 months). 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 21 Apr 2023.