Rotator Cuff Tears of the ShoulderNCT06648941
Evaluation of Medial Supraspinatus Muscle Release in Treatment of Retracted Rotator Cuff Tear
A study testing Muscle release in people with Rotator Cuff Tears of the Shoulder, run by Sohag University at 1 site in Egypt.
Trial summary
Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder
- What is being tested?
- Muscle release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 35-65 years
- Diagnosed with retracted rotator cuff tear confirmed by MRI
- Failed conservative treatment for at least 6 months
- Informed consent provided
- Exclusion Criteria
- Previous fracture around shoulder on the affected side
Show all 9Show fewer
- shoulder infection on the affected side
- Axillary nerve injury
- Previous shoulder surgery on the affected side
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
- Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. When the supraspinatus tendon tears and retracts, surgical intervention is often necessary to restore function and alleviate symptoms. (1) Traditional surgical approaches for retracted rotator cuff tears typically involve reattaching the tendon to the greater tuberosity of the humerus. However, severe retraction can lead to challenges during repair, including increased tension on the repair site, potentially compromising healing and increasing the risk of re-tears. • Partial Repair with or without Augmentation: In cases of moderate retraction where complete tendon mobilization is challenging, a partial repair combined with augmentation techniques (e.g., patch augmentation, autografts, allografts) may be considered to optimize tendon-to-bone healing.
- Tendon Transfer: For massive irreparable tears or poor tendon quality, tendon transfer procedures (e.g., transferring the teres minor or lower trapezius tendon) may be necessary to restore function and shoulder stability. (2) To address these challenges, medial release of the supraspinatus tendon from its attachment on the medial border of the scapula has emerged as a promising technique.
Medial release involves detaching the supraspinatus tendon from its scapular attachment and mobilizing it medially. This technique aims to reduce tension at the repair site, allowing for better tendon apposition and potentially improving healing outcomes. Proponents suggest that medial release enhances biomechanical strength and reduces the risk of postoperative complications such as re-tears. However, the technique's optimal application, outcomes, and comparative effectiveness against traditional repair methods remain subjects of ongoing research and debate within the orthopedic community. (3)
Read more
Given the complexity and variability of retracted rotator cuff tears, a systematic evaluation of medial release is crucial to clarify its efficacy, safety, and role in surgical management. This protocol outlines a comprehensive framework for evaluating medial release of the supraspinatus tendon in the repair of retracted rotator cuff tears. The study aims to provide evidence-based insights that can guide surgical decision-making, improve patient outcomes, and advance the field of shoulder surgery.
Furthermore, medial release may enhance the biomechanical integrity of the repair. By optimizing tendon positioning and tension during repair, it could improve the mechanical strength of the repair construct. This aspect is crucial for achieving durable outcomes and preventing repair failure over time..
- Conditions
- Rotator Cuff Tears of the Shoulder
- Being tested
- Muscle release
- Keywords
- rotator cuff tear, supraspinatus muscle
- 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.
Muscle releaseProcedure or surgery
supraspinatus muscle release
| Study group | Role | What they receive |
|---|---|---|
| Supraspinatus muscle release | Other | supraspinatus muscle release in retracted rotator cuff tear Receives: Procedure: Muscle release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain score ( vas) score
Improvement in pain score ( vas) score at 12 months.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tears of the ShoulderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hemaid Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648941
- Sponsor's protocol ID
- Soh-Med-24-08-01MD
- Other IDs
- no one
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Evaluation of medial supraspinatus muscle release in retracted rotator cuff tear
Publications
Burkhart SS, Danaceau SM, Pearce CE Jr. Arthroscopic rotator cuff repair: Analysis of results by tear size and by repair technique-margin convergence versus direct tendon-to-bone repair. Arthroscopy. 2001 Nov-Dec;17(9):905-12. doi: 10.1053/jars.2001.26821.
PubMed 11694920Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000 Apr;82(4):505-15. doi: 10.2106/00004623-200004000-00006.
PubMed 10761941Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
PubMed 15930531
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medial Supraspinatus Muscle Release in Treatment of Retracted Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT06648941
- Acronym / sponsor ID
- Soh-Med-24-08-01MD
- Conditions
- Rotator Cuff Tears of the Shoulder
- Keywords
- rotator cuff tear, supraspinatus muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Oct 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.
- Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. When the supraspinatus tendon tears and retracts, surgical intervention is often necessary to restore function and alleviate symptoms. (1) Traditional surgical approaches for retracted rotator cuff tears typically involve reattaching the tendon to the greater tuberosity of the humerus. However, severe retraction can lead to challenges during repair, including increased tension on the repair site, potentially compromising healing and increasing the risk of re-tears. • Partial Repair with or without Augmentation: In cases of moderate retraction where complete tendon mobilization is challenging, a partial repair combined with augmentation techniques (e.g., patch augmentation, autografts, allografts) may be considered to optimize tendon-to-bone healing.
- Tendon Transfer: For massive irreparable tears or poor tendon quality, tendon transfer procedures (e.g., transferring the teres minor or lower trapezius tendon) may be necessary to restore function and shoulder stability. (2) To address these challenges, medial release of the supraspinatus tendon from its attachment on the medial border of the scapula has emerged as a promising technique.
Medial release involves detaching the supraspinatus tendon from its scapular attachment and mobilizing it medially. This technique aims to reduce tension at the repair site, allowing for better tendon apposition and potentially improving healing outcomes. Proponents suggest that medial release enhances biomechanical strength and reduces the risk of postoperative complications such as re-tears. However, the technique's optimal application, outcomes, and comparative effectiveness against traditional repair methods remain subjects of ongoing research and debate within the orthopedic community. (3)
Given the complexity and variability of retracted rotator cuff tears, a systematic evaluation of medial release is crucial to clarify its efficacy, safety, and role in surgical management. This protocol outlines a comprehensive framework for evaluating medial release of the supraspinatus tendon in the repair of retracted rotator cuff tears. The study aims to provide evidence-based insights that can guide surgical decision-making, improve patient outcomes, and advance the field of shoulder surgery.
Furthermore, medial release may enhance the biomechanical integrity of the repair. By optimizing tendon positioning and tension during repair, it could improve the mechanical strength of the repair construct. This aspect is crucial for achieving durable outcomes and preventing repair failure over time..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraspinatus muscle release | Other | Procedure: Muscle releasesupraspinatus muscle release in retracted rotator cuff tear |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 35-65 years
- Diagnosed with retracted rotator cuff tear confirmed by MRI
- Failed conservative treatment for at least 6 months
- Informed consent provided
- Previous fracture around shoulder on the affected side
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Muscle releasesupraspinatus muscle release | Procedure or surgery | Supraspinatus muscle release |
Primary outcome
Improvement in pain score ( vas) score
Time frame: one year
Improvement in pain score ( vas) score at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 11694920Burkhart SS, Danaceau SM, Pearce CE Jr. Arthroscopic rotator cuff repair: Analysis of results by tear size and by repair technique-margin convergence versus direct tendon-to-bone repair. Arthroscopy. 2001 Nov-Dec;17(9):905-12. doi: 10.1053/jars.2001.26821.
- Background: PubMed 10761941Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000 Apr;82(4):505-15. doi: 10.2106/00004623-200004000-00006.
- Background: PubMed 15930531Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
- Individual participant dataSharing planned: Yes. Evaluation of medial supraspinatus muscle release in retracted rotator cuff tear
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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 Muscle release in people with Rotator Cuff Tears of the Shoulder, 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Oct 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?
Results are not available in the source record.
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?
Improvement in pain score ( vas) score (time frame: one year). 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 NCT06648941, which also lists 3 linked publications.
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 18 Oct 2024.