Rotator Cuff TearsNCT06743061
Long-Term Follow-up of Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears
An observational study of Rotator Cuff Tears, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Post-Op Follow Up
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2018to 23 Jul 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: From Oct 2018 to Jan 2021, 23 patients who had chronic massive RCTs received arthroscopic management for their RCTs and were followed as short-term follow-up for 3 months after surgery. Then, patients were asked to attend the Orthopedic outpatient clinic every three months for assessment to get the outcomes of the long-term follow-up. The preoperative, operative, immediate postoperative, and short-term follow-up data were collected from patients' files.
Who may be able to join
- Patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears
Who cannot join
- Patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Arthroscopic Debridement, Subacromial Decompression, and Biceps Tenotomy Without Repair of Rotator Cuff in Chronic Massive Rotator Cuff Tear
Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing MMRCTs is not fully understood. A comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling.
The study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. By analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. Furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.
- Conditions
- Rotator Cuff Tears
- Being tested
- Post-Op Follow Up
- 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.
Post-Op Follow UpBehavioural
Post Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Not described Receives: Behavioral: Post-Op Follow Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients reported having at least a 50% obtaining the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.
The Success rate of Arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator cuff tear in making the patients able to obtain the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.
Measured: 42 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start19 Nov 2018
- Primary completion20 Nov 2021
- Study completion23 Jul 2024
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 Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ghanem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743061
- Sponsor's protocol ID
- RC-1911-2018
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Arthroscopic Debridement, Subacromial Decompression, and Biceps Tenotomy Without Repair of Rotator Cuff in Chronic Massive Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT06743061
- Acronym / sponsor ID
- RC-1911-2018
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 19 Dec 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.
Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing MMRCTs is not fully understood. A comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling.
The study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. By analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. Furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Behavioral: Post-Op Follow Up |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From Oct 2018 to Jan 2021, 23 patients who had chronic massive RCTs received arthroscopic management for their RCTs and were followed as short-term follow-up for 3 months after surgery. Then, patients were asked to attend the Orthopedic outpatient clinic every three months for assessment to get the outcomes of the long-term follow-up. The preoperative, operative, immediate postoperative, and short-term follow-up data were collected from patients' files.
Key inclusion criteria (1 listed)
- Patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears
Key exclusion criteria (1 listed)
- Patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears
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 |
|---|---|---|
| Post-Op Follow UpPost Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears. | Behavioural | Group I |
Primary outcome
The proportion of patients reported having at least a 50% obtaining the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.
Time frame: 42 Months
The Success rate of Arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator cuff tear in making the patients able to obtain the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.
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 19 Dec 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.
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?
An observational study of Rotator Cuff Tears, run by Cairo 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 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: finished, as of the sponsor's last update on 19 Dec 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?
The proportion of patients reported having at least a 50% obtaining the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance. (time frame: 42 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 19 Dec 2024.