Clinical trial NCT02073695: Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
Official title: Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: Proximal humeral fracture
Shoulder
Orthopaedics
Neutral rotation brace
Polysling
Lead sponsor: Torbay and South Devon NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Oxford score
timeFrame: 1 Year post surgery
measure: DASH - the Disabilities of the Arm, Shoulder and Hand
timeFrame: 1 year post surgery
Secondary outcomes:
measure: Range of movement(flexion, extension, abduction, external and internal rotation)
timeFrame: 6 weeks, 3 months and 1 year
measure: SF-12 Score
timeFrame: 1 Year post surgery
measure: Range of movement (flexion, extension, abduction and internal rotation)
timeFrame: 6 weeks, 6 months and 1 year
measure: Time to union of fracture
timeFrame: 6 weeks and 3 Months
measure: Return to work post surgery
timeFrame: 1 year follow up
measure: Re-operations and Complications
timeFrame: Throughout 1st year as applicable at outpatient appointments
Other outcomes:
Locations:
city: Torquay
country: United Kingdom
facility: Torbay District General Hospital
Study officials:
affiliation: South Devon Healthcare
name: Veronica Conboy, FRCS (Orth)
role: PRINCIPAL_INVESTIGATOR
References:
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.