Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
NCT ID: NCT02073695
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2013-01-31
2013-12-31
Brief Summary
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Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?
Primary objectives:
To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.
Benefits:
There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.
Risks/disadvantages:
The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Neutral Rotation Brace
Neutral Rotation Brace
Operative procedure to fix proximal humeral
Operative fixation by the shoulder team at Torbay Hospital
Neutral Rotation Brace
Performed at the end of the surgical procedure at Torbay Hospital
Physiotherapy review
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
Functional outcome forms filled in
Postal functional outcome scores
Sent to patient at 9 weeks post surgery
Post-operative Radiographs
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
Standard polysling (Current practice)
Standard polysling (Current practice)
Operative procedure to fix proximal humeral
Operative fixation by the shoulder team at Torbay Hospital
Neutral Rotation Brace
Performed at the end of the surgical procedure at Torbay Hospital
Physiotherapy review
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
Functional outcome forms filled in
Postal functional outcome scores
Sent to patient at 9 weeks post surgery
Post-operative Radiographs
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
Interventions
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Operative procedure to fix proximal humeral
Operative fixation by the shoulder team at Torbay Hospital
Neutral Rotation Brace
Performed at the end of the surgical procedure at Torbay Hospital
Physiotherapy review
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
Functional outcome forms filled in
Postal functional outcome scores
Sent to patient at 9 weeks post surgery
Post-operative Radiographs
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age over 18 years of age
* Patient able to give informed consent
Exclusion Criteria
* Patients under 18 years of age
* Patients unable to give informed consent
18 Years
ALL
No
Sponsors
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Torbay and South Devon NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Veronica Conboy, FRCS (Orth)
Role: PRINCIPAL_INVESTIGATOR
South Devon Healthcare
Locations
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Torbay District General Hospital
Torquay, , United Kingdom
Countries
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References
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Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Other Identifiers
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13/01/049
Identifier Type: -
Identifier Source: org_study_id
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