Rotator Cuff TearHBStud2NCT01140230
Outcomes After Repair of Acute Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by University Hospital, Linkoeping.
Trial summary
Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes. Read more about this study
- Who is it for?
- Ages 42 to 83 years
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to May 2010
- 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 42 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective review of our computerized database identified 49 patients repaired at our institution between May 2004 until May 2009 due to acute traumatic rotator cuff tears. 42 patients who fulfilled the inclusion criteria, were willing to participate in a follow-up evaluation after written and oral informed consent.
Who may be able to join
- significant trauma to the shoulder
- sudden onset of symptoms
- asymptomatic in the shoulder before trauma
- pseudoparalysis in the shoulder after trauma
- full thickness rotator cuff tear of at least one tendon
Who cannot join
- patients with previous or gradual onset of symptoms in the traumatised shoulder
- partial rotator cuff tear
- displaced fracture
About this study
Official title: Structural and Clinical Outcomes After Repair of Acute Rotator Cuff Tears
Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, rotator cuff repair, age, timing to surgery
- Medical subject headings
- Rotator Cuff Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Investigators
- Lars Adolfsson, Associate Professor, Study director, Department of Orthopeadic, Linkoeping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140230
- Sponsor's protocol ID
- Hanna Björnsson study 2
- Acronym
- HBStud2
- Status last verified
- Sep 2009
- First submitted
- 8 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
PubMed 6839586Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.
PubMed 17621294
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Clinical Outcomes After Repair of Acute Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01140230
- Acronym / sponsor ID
- HBStud2 / Hanna Björnsson study 2
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, rotator cuff repair, age, timing to surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Jun 2010 (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.
Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 42 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective review of our computerized database identified 49 patients repaired at our institution between May 2004 until May 2009 due to acute traumatic rotator cuff tears. 42 patients who fulfilled the inclusion criteria, were willing to participate in a follow-up evaluation after written and oral informed consent.
Key inclusion criteria (5 listed)
- significant trauma to the shoulder
- sudden onset of symptoms
- asymptomatic in the shoulder before trauma
- pseudoparalysis in the shoulder after trauma
- full thickness rotator cuff tear of at least one tendon
Key exclusion criteria (3 listed)
- patients with previous or gradual onset of symptoms in the traumatised shoulder
- partial rotator cuff tear
- displaced fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 9 Jun 2010.
- Background: PubMed 6839586Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
- Background: PubMed 17621294Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.
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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.
Lars Adolfsson, Associate Professor study director
Department of Orthopeadic, Linkoeping University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by University Hospital, Linkoeping.
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 5 inclusion and 3 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 9 Jun 2010. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140230, which also lists 2 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 9 Jun 2010.