Rotator Cuff TearNCT00828256
Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008
An observational study of Rotator Cuff Tear, run by Soroka University Medical Center.
Trial summary
Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- arthroscopy of shoulder
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jun 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 patients, above 18 years of age, who had had an arthroscopic repair of chronic rotator cuff tear between the years 2005-2008.
Who may be able to join
- Age over 18 years
- Arthroscopic repair of chronic rotator cuff tear
- Operation done after January 2005
Who cannot join
None listed.
About this study
Official title: Outcome Study of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008, at the Soroka University Medical Center, Beer Sheva, Israel
Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results.
The aim of this study is to estimate the anatomic and functional results of the arthroscopic repair among the patients of the orthopedic department at the Soroka University Medical Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair of the rotator cuff is the better surgical technique.
Read more
Methods: study population - 80 patients who had had an arthroscopic repair of the rotator cuff between the years 2005-2008 at the SUMC.
Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation not before 2005.
Study design:
- Data base Collection.
- Inviting the patients for physical examination + ultrasound examination of the operated shoulder + filling out questionnaires (SF36, CONSTANT SCORE)
- Statistical analysis
- Publication
- Conditions
- Rotator Cuff Tear
- Being tested
- arthroscopy of shoulder
- Keywords
- arthroscopic repair, rotator cuff, tears, shoulder, chronic tear of rotator cuff
- Medical subject headings
- Rotator Cuff Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopy of shoulderProcedure or surgery
arthroscopic repair of chronic rotator cuff tears
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of an anatomic repair of the rotator cuff proved by ultrasound
Measured: immidiate
Secondary outcomes (1)
high constant score
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828256
- Sponsor's protocol ID
- sor477308ctil
- Other IDs
- isrctn9930305
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008, at the Soroka University Medical Center, Beer Sheva, Israel
- ClinicalTrials.gov ID
- NCT00828256
- Acronym / sponsor ID
- sor477308ctil
- Conditions
- Rotator Cuff Tear
- Keywords
- arthroscopic repair, rotator cuff, tears, shoulder, chronic tear of rotator cuff
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 23 Jan 2009 (estimated)
- 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.
Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results.
The aim of this study is to estimate the anatomic and functional results of the arthroscopic repair among the patients of the orthopedic department at the Soroka University Medical Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair of the rotator cuff is the better surgical technique.
Methods: study population - 80 patients who had had an arthroscopic repair of the rotator cuff between the years 2005-2008 at the SUMC.
Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation not before 2005.
Study design:
- Data base Collection.
- Inviting the patients for physical examination + ultrasound examination of the operated shoulder + filling out questionnaires (SF36, CONSTANT SCORE)
- Statistical analysis
- Publication
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients, above 18 years of age, who had had an arthroscopic repair of chronic rotator cuff tear between the years 2005-2008.
Key inclusion criteria (3 listed)
- Age over 18 years
- Arthroscopic repair of chronic rotator cuff tear
- Operation done after January 2005
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 |
|---|---|---|
| arthroscopy of shoulderarthroscopic repair of chronic rotator cuff tears | Procedure or surgery | – |
Primary outcome
evidence of an anatomic repair of the rotator cuff proved by ultrasound
Time frame: immidiate
1 secondary outcome
high constant score
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Soroka University Medical Center.
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 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 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
evidence of an anatomic repair of the rotator cuff proved by ultrasound (time frame: immidiate). 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 23 Jan 2009.