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

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

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

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust

  lead OTHER

Principal Investigators

• Veronica Conboy, FRCS (Orth) · South Devon Healthcare

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United Kingdom

Study Locations