NCT02073695

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

February 21, 2014

Last Update Submit

July 17, 2019

Conditions

Proximal Humeral Fracture

Keywords

Proximal humeral fractureShoulderOrthopaedicsNeutral rotation bracePolysling

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

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

    6 weeks, 3 months and 1 year

  • SF-12 Score

    1 Year post surgery

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

    6 weeks, 6 months and 1 year

  • Time to union of fracture

    6 weeks and 3 Months

  • Return to work post surgery

    1 year follow up

  • +1 more secondary outcomes

Study Arms (2)

Neutral Rotation Brace

OTHER

Neutral Rotation Brace

Procedure: Operative procedure to fix proximal humeralDevice: Neutral Rotation BraceOther: Physiotherapy reviewOther: Functional outcome forms filled inOther: Postal functional outcome scoresOther: Post-operative Radiographs

Standard polysling (Current practice)

OTHER

Standard polysling (Current practice)

Procedure: Operative procedure to fix proximal humeralDevice: Neutral Rotation BraceOther: Physiotherapy reviewOther: Functional outcome forms filled inOther: Postal functional outcome scoresOther: Post-operative Radiographs

Interventions

Operative procedure to fix proximal humeralPROCEDURE

Operative fixation by the shoulder team at Torbay Hospital

Neutral Rotation BraceStandard polysling (Current practice)
Neutral Rotation BraceDEVICE

Performed at the end of the surgical procedure at Torbay Hospital

Neutral Rotation BraceStandard polysling (Current practice)
Physiotherapy reviewOTHER

Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.

Neutral Rotation BraceStandard polysling (Current practice)
Functional outcome forms filled inOTHER
Also known as: Oxford, DASH, SF-12
Neutral Rotation BraceStandard polysling (Current practice)
Postal functional outcome scoresOTHER

Sent to patient at 9 weeks post surgery

Neutral Rotation BraceStandard polysling (Current practice)
Post-operative RadiographsOTHER

Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital

Neutral Rotation BraceStandard polysling (Current practice)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torbay District General Hospital

Torquay, TQ2 7AA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Veronica Conboy, FRCS (Orth)

    South Devon Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 27, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

GB(1)