Rotator Cuff TearsNCT06394856
Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
A study testing Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques in people with Rotator Cuff Tears, run by Sohag University at 1 site in Egypt.
Trial summary
rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population . Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Jul 2021
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full-thickness supraspinatus
- degenerative tears
- age range 40 :65
Who cannot join
- subscapularis tear
- small and massive tears
- traumatic tears
- partial -thickness tear
- revisioin surgery
- glenohumeral arthretic changes and shoulder instability
Trial locations and contacts
1 site in 1 country.
About this study
rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .
Read the detailed description
accompanied by shoulder pain and dysfunction
- Conditions
- Rotator Cuff Tears
- Being tested
- Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
- 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.
Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge TechniquesProcedure or surgery
rotator cuff tears with modified versus classic double row suture bridge
| Study group | Role | What they receive |
|---|---|---|
| knotless group | Active comparator | rotator cuff repair with a modified knotless anchors Receives: Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques |
| knot-tying group | Active comparator | rotator cuff repair with classic knot-tying double-row suture bridge technique by classic anchors Receives: Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
retear rate
retear rate
Measured: 3 years
Secondary outcomes (1)
time
duration of operation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jul 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldin Mohamed Ahmed ElAzab, Sohag University
- Investigators
- Hossam M azab, MD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394856
- Sponsor's protocol ID
- Soh-Med-23-04-01
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
- ClinicalTrials.gov ID
- NCT06394856
- Acronym / sponsor ID
- Soh-Med-23-04-01
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 1 May 2024 (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.
rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .
Detailed description
accompanied by shoulder pain and dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knotless group | Active comparator | Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniquesrotator cuff repair with a modified knotless anchors |
| knot-tying group | Active comparator | Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniquesrotator cuff repair with classic knot-tying double-row suture bridge technique by classic anchors |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- full-thickness supraspinatus
- degenerative tears
- age range 40 :65
Key exclusion criteria (6 listed)
- subscapularis tear
- small and massive tears
- traumatic tears
- partial -thickness tear
- revisioin surgery
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 |
|---|---|---|
| Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniquesrotator cuff tears with modified versus classic double row suture bridge | Procedure or surgery | knot-tying group, knotless group |
Primary outcome
retear rate
Time frame: 3 years
retear rate
1 secondary outcome
time
Time frame: 3 years
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 13 Jun 2024.
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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.
Hossam M azab, MD study chair
Sohag 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 Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques in people with Rotator Cuff Tears, run by Sohag University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 13 Jun 2024. 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 Egypt. 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?
retear rate (time frame: 3 years). 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 13 Jun 2024.