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

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 Overview

• Status: Terminated
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Neutral Rotation Brace	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 Names: Oxford; DASH; SF-12; 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
OTHER: Standard polysling (Current practice)	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 Names: Oxford; DASH; SF-12; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 year post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	6 weeks, 6 months and 1 year
Time to union of fracture	X-Rays taken	6 weeks and 3 Months
Return to work post surgery		1 year follow up
Re-operations and Complications	Documented at various outpatient appointments	Throughout 1st year as applicable at outpatient appointments

Collaborators and Investigators

• Sponsor: Torbay and South Devon NHS Foundation Trust
• Investigators: Principal Investigator: Veronica Conboy, FRCS (Orth), South Devon Healthcare

Publications and helpful links

General Publications

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (ESTIMATE): February 27, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Shoulder; Orthopaedics; Proximal humeral fracture; Neutral rotation brace; Polysling
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 13/01/049