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

Torbay and South Devon NHS Foundation Trust

Status: Terminated

Conditions: Proximal Humeral Fracture

Treatments: Device: Neutral Rotation Brace; Other: Postal functional outcome scores; Other: Functional outcome forms filled in; Procedure: Operative procedure to fix proximal humeral; Other: Physiotherapy review; Other: Post-operative Radiographs

Study type: Interventional

Funder types: Other

Identifiers

NCT02073695

13/01/049

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
• Age over 18 years of age
• Patient able to give informed consent

Exclusion criteria

• Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
• Patients under 18 years of age
• Patients unable to give informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Neutral Rotation Brace

Other group

Description:

Neutral Rotation Brace

Treatment:

Device: Neutral Rotation Brace

Other: Functional outcome forms filled in

Other: Post-operative Radiographs

Procedure: Operative procedure to fix proximal humeral

Other: Physiotherapy review

Other: Postal functional outcome scores

Standard polysling (Current practice)

Other group

Description:

Standard polysling (Current practice)

Treatment:

Device: Neutral Rotation Brace

Other: Functional outcome forms filled in

Other: Post-operative Radiographs

Procedure: Operative procedure to fix proximal humeral

Other: Physiotherapy review

Other: Postal functional outcome scores