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

Not Applicable

Terminated

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

• Registration Number: NCT02073695
• Lead Sponsor: Torbay and South Devon NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard polysling (Current practice)	Neutral Rotation Brace	Standard polysling (Current practice)
Standard polysling (Current practice)	Functional outcome forms filled in	Standard polysling (Current practice)
Neutral Rotation Brace	Functional outcome forms filled in	Neutral Rotation Brace
Neutral Rotation Brace	Postal functional outcome scores	Neutral Rotation Brace
Neutral Rotation Brace	Post-operative Radiographs	Neutral Rotation Brace
Neutral Rotation Brace	Operative procedure to fix proximal humeral	Neutral Rotation Brace
Neutral Rotation Brace	Physiotherapy review	Neutral Rotation Brace
Standard polysling (Current practice)	Postal functional outcome scores	Standard polysling (Current practice)
Standard polysling (Current practice)	Post-operative Radiographs	Standard polysling (Current practice)
Neutral Rotation Brace	Neutral Rotation Brace	Neutral Rotation Brace
Standard polysling (Current practice)	Physiotherapy review	Standard polysling (Current practice)
Standard polysling (Current practice)	Operative procedure to fix proximal humeral	Standard polysling (Current practice)

Primary Outcome Measures

Name	Time	Method
DASH - the Disabilities of the Arm, Shoulder and Hand	1 year post surgery	DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function
Oxford score	1 Year post surgery	Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire

Secondary Outcome Measures

Name	Time	Method
Range of movement(flexion, extension, abduction, external and internal rotation)	6 weeks, 3 months and 1 year	Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement
SF-12 Score	1 Year post surgery	This survey form has been shown to yield summary physical and mental health outcome scores
Range of movement (flexion, extension, abduction and internal rotation)	6 weeks, 6 months and 1 year	Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement
Time to union of fracture	6 weeks and 3 Months	X-Rays taken
Return to work post surgery	1 year follow up
Re-operations and Complications	Throughout 1st year as applicable at outpatient appointments	Documented at various outpatient appointments

Trial Locations

Locations (1)

Torbay District General Hospital; 🇬🇧 Torquay, United Kingdom