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

Primary Purpose

Proximal Humeral Fracture

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Operative procedure to fix proximal humeral
Neutral Rotation Brace
Physiotherapy review
Functional outcome forms filled in
Postal functional outcome scores
Post-operative Radiographs
Sponsored by
Torbay and South Devon NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Proximal Humeral Fracture focused on measuring Proximal humeral fracture, Shoulder, Orthopaedics, Neutral rotation brace, Polysling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Torbay District General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Neutral Rotation Brace

Standard polysling (Current practice)

Arm Description

Neutral Rotation Brace

Standard polysling (Current practice)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
SF-12 Score
This survey form has been shown to yield summary physical and mental health outcome scores
Range of movement (flexion, extension, abduction and internal rotation)
Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement
Time to union of fracture
X-Rays taken
Return to work post surgery
Re-operations and Complications
Documented at various outpatient appointments

Full Information

First Posted
February 21, 2014
Last Updated
July 17, 2019
Sponsor
Torbay and South Devon NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02073695
Brief Title
Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
Acronym
ROTATE
Official Title
Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torbay and South Devon NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
Proximal humeral fracture, Shoulder, Orthopaedics, Neutral rotation brace, Polysling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutral Rotation Brace
Arm Type
Other
Arm Description
Neutral Rotation Brace
Arm Title
Standard polysling (Current practice)
Arm Type
Other
Arm Description
Standard polysling (Current practice)
Intervention Type
Procedure
Intervention Name(s)
Operative procedure to fix proximal humeral
Intervention Description
Operative fixation by the shoulder team at Torbay Hospital
Intervention Type
Device
Intervention Name(s)
Neutral Rotation Brace
Intervention Description
Performed at the end of the surgical procedure at Torbay Hospital
Intervention Type
Other
Intervention Name(s)
Physiotherapy review
Intervention Description
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
Intervention Type
Other
Intervention Name(s)
Functional outcome forms filled in
Other Intervention Name(s)
Oxford, DASH, SF-12
Intervention Type
Other
Intervention Name(s)
Postal functional outcome scores
Intervention Description
Sent to patient at 9 weeks post surgery
Intervention Type
Other
Intervention Name(s)
Post-operative Radiographs
Intervention Description
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
Primary Outcome Measure Information:
Title
Oxford score
Description
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
Title
DASH - the Disabilities of the Arm, Shoulder and Hand
Description
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 Outcome Measure Information:
Title
Range of movement(flexion, extension, abduction, external and internal rotation)
Description
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
Title
SF-12 Score
Description
This survey form has been shown to yield summary physical and mental health outcome scores
Time Frame
1 Year post surgery
Title
Range of movement (flexion, extension, abduction and internal rotation)
Description
Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement
Time Frame
6 weeks, 6 months and 1 year
Title
Time to union of fracture
Description
X-Rays taken
Time Frame
6 weeks and 3 Months
Title
Return to work post surgery
Time Frame
1 year follow up
Title
Re-operations and Complications
Description
Documented at various outpatient appointments
Time Frame
Throughout 1st year as applicable at outpatient appointments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Conboy, FRCS (Orth)
Organizational Affiliation
South Devon Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torbay District General Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
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.
Results Reference
derived

Learn more about this trial

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

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