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

Proximal Humeral Fracture Clinical Trial

— ROTATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02073695
• Other study ID #: 13/01/049
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2019
• Source: Torbay and South Devon NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

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.
• Functional outcome forms filled in

• Postal functional outcome scores
Sent to patient at 9 weeks post surgery
• Post-operative Radiographs
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital

Locations

Country	Name	City	State
United Kingdom	Torbay District General Hospital	Torquay

Sponsors (1)

Lead Sponsor	Collaborator
Torbay and South Devon NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	SF-12 Score	This survey form has been shown to yield summary physical and mental health outcome scores	1 Year post surgery
Secondary	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
Secondary	Time to union of fracture	X-Rays taken	6 weeks and 3 Months
Secondary	Return to work post surgery		1 year follow up
Secondary	Re-operations and Complications	Documented at various outpatient appointments	Throughout 1st year as applicable at outpatient appointments