Trial record 3 of 4 for:    Open Studies | "Ulna Fractures"

A Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Royal Infirmary of Edinburgh
Sponsor:
Information provided by (Responsible Party):
Mr. AD Duckworth, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier:
NCT01397643
First received: July 18, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures within the elderly population with one case series in the literature describing 13 patients. Our trial includes all patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two treatment methods. Patients in the nonoperative group will be place in a sling for two weeks and then allowed to mobilise under supervised physiotherapy as per normal protocol. For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Patients will be evaluated over a one year period following their treatment.


Condition Intervention
Displaced Olecranon Fractures in Elderly Patients
Other: Non-operative
Other: Operative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly

Resource links provided by NLM:


Further study details as provided by Royal Infirmary of Edinburgh:

Primary Outcome Measures:
  • DASH [ Time Frame: One year ] [ Designated as safety issue: No ]
    Patient reported outcome measure specific to upper limb - DASH questionnaire at one year post injury/surgery.


Secondary Outcome Measures:
  • Mayo Elbow Performance Index (MEPI [ Time Frame: One year ] [ Designated as safety issue: No ]
    Completion of the Mayo Elbow Performance Index (MEPI), a physician rate scale of function will completed for all patients15. The MEPI is a validated hundred-point system based upon pain (forty five points), range of motion (twenty points), stability (ten points) and daily function (twenty five points). Categorical ratings are assigned as follows: ninety to one hundred points is rated excellent; seventy-five to eighty-nine, good; sixty to seventy-four, fair; and less than sixty points, poor.

  • Range of motion [ Time Frame: One year ] [ Designated as safety issue: No ]
    Range of motion at the elbow and forearm: will be measured using a standard full circle goniometer. Flexion, extension, supination and prontation will be measured in triplicate and the mean recorded to minimise intra-observer bias.

  • Pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    Pain assessment on an analogue scale 1-10.

  • Time taken to return to activities [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time taken to return to activities of daily living/work/sport

  • Radiographic Assessment [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Radiographic assessment used standard anteroposterior (AP) and lateral radiographs of the elbow. Outcome will also be assessed in detail with regards to loss of fracture reduction, complications, union and the development of radiographic degenerative changes +/- pseudoarthrosis.


Estimated Enrollment: 70
Study Start Date: October 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non-operative
Patients in the non-operative arm will be managed conservatively using a sling, or an above elbow lightweight cast if problems with pain, for 10-14 days post injury. Patients will then be allowed to mobilise as able.
Other: Non-operative
Patients in the non-operative arm will be managed conservatively using a sling, or an above elbow lightweight cast if problems with pain, for 10-14 days post injury. Patients will then be allowed to mobilise as able.
Operative
Patients in this arm will be managed operatively for their olecranon fracture using either tension band wiring or plate fixation.
Other: Operative
For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Following surgery, the post-operative assessment and course will be as per normal protocol for patients who are not in this study. Patients in the operative group will be immobilised depending on fracture fixation during surgery and the decision will be made by the treating surgeon. Physiotherapy will be arranged when required.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥75 years
  • Minimal, moderate or severe fragmentation of the olecranon
  • Within two weeks of olecranon fracture

Exclusion Criteria:

  • Patients unable to give informed consent
  • Associated fractures to the coronoid, radial head and/or distal humerus
  • Associated ligamentous injury, dislocation or subluxation
  • Open fractures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397643

Contacts
Contact: Andrew D Duckworth, MSc, MRCSEd +447769701875 andrew.duckworth@yahoo.co.uk
Contact: Margaret M McQueen, MD, FRCSEd 0131 242 3427 mmcqueen@staffmail.ed.ac.uk

Locations
United Kingdom
Department of Orthopaedic Surgery, Fife (Dunfermline and Kirkcaldy) Recruiting
Dunfermline, Fife, United Kingdom, KY12 0SU
Contact: Phil J Walmsley, FRCSEd    01383 623623    phil.walmsley@nhs.net   
Contact: Jane McEachan, FRCSEd       jane@mceachan.co.uk   
Principal Investigator: Phil J Walmsley, FRCSEd         
Sub-Investigator: Jane Mceachan, FRCSEd         
Edinburgh Orthopaedic Trauma Unit Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SU
Contact: Andrew D Duckworth, MSc, MRCSEd    +447769701875    andrew.duckworth@yahoo.co.uk   
Contact: Margaret M McQueen, MD, FRCSEd    0131 242 3427    mmcqueen@staffmail.ed.ac.uk   
Sub-Investigator: Andrew D Duckworth, MSc, MRCSEd         
Principal Investigator: Margaret M McQueen, MD, FRCSEd         
Sponsors and Collaborators
Mr. AD Duckworth
Investigators
Principal Investigator: Margaret M McQueen, MD, FRCSEd Edinburgh Orthopaedic Trauma Unit
  More Information

Publications:
Responsible Party: Mr. AD Duckworth, StR, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT01397643     History of Changes
Other Study ID Numbers: 2010/R/OST/05
Study First Received: July 18, 2011
Last Updated: May 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Ulna Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 29, 2014