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

N/ATerminatedNCT02073695

Torbay and South Devon NHS Foundation Trust2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Proximal Humeral Fracture

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oxford score

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

Time frame: 1 Year post surgery

DASH - the Disabilities of the Arm, Shoulder and Hand

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

Time frame: 1 year post surgery

Secondary Outcomes

Range of movement(flexion, extension, abduction, external and internal rotation)

Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement

Time frame: 6 weeks, 3 months and 1 year

SF-12 Score

This survey form has been shown to yield summary physical and mental health outcome scores

Time frame: 1 Year post surgery

Range of movement (flexion, extension, abduction and internal rotation)

Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement

Time frame: 6 weeks, 6 months and 1 year

Time to union of fracture

X-Rays taken

Time frame: 6 weeks and 3 Months

Return to work post surgery

Time frame: 1 year follow up

Re-operations and Complications

Documented at various outpatient appointments

Time frame: Throughout 1st year as applicable at outpatient appointments