NCT02073695

Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Torbay and South Devon NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Research question: 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.

Conditions

• Proximal Humeral Fracture

Interventions

Type	Name	Description
PROCEDURE	Operative procedure to fix proximal humeral	Operative fixation by the shoulder team at Torbay Hospital
DEVICE	Neutral Rotation Brace	Performed at the end of the surgical procedure at Torbay Hospital
OTHER	Physiotherapy review	Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
OTHER	Functional outcome forms filled in
OTHER	Postal functional outcome scores	Sent to patient at 9 weeks post surgery
OTHER	Post-operative Radiographs	Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-02-27
• Last updated: 2019-07-18

Locations

1 site across 1 country: United Kingdom