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

NCT01397643 | Terminated

• 1 other identifier: 2010/R/OST/05
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Olecranon Fractures in the Elderly

Outcome Measures

Primary Outcomes (1)

• DASH

  Patient reported outcome measure specific to upper limb - DASH questionnaire at one year post injury/surgery.

  One year

Secondary Outcomes (5)

• Mayo Elbow Performance Index (MEPI

  One year

• Range of motion

  One year

• Pain

  One year

• Time taken to return to activities

  One year

• Radiographic Assessment

  Six months

Study Arms (2)

Non-operative

OTHER

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

Operative

OTHER

Patients in this arm will be managed operatively for their olecranon fracture using either tension band wiring or plate fixation.

Other: Operative

Interventions

Non-operative OTHER

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.

Non-operative

Operative OTHER

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.

Operative

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew D Duckworth: lead

Study Sites (2)

Department of Orthopaedic Surgery, Fife (Dunfermline and Kirkcaldy)

Dunfermline, Fife, KY12 0SU, United Kingdom

Location

Edinburgh Orthopaedic Trauma Unit

Edinburgh, Lothian, EH16 4SU, United Kingdom

Location

Related Publications (8)

• Rommens PM, Kuchle R, Schneider RU, Reuter M. Olecranon fractures in adults: factors influencing outcome. Injury. 2004 Nov;35(11):1149-57. doi: 10.1016/j.injury.2003.12.002.

  PMID: 15488508 BACKGROUND

• Villanueva P, Osorio F, Commessatti M, Sanchez-Sotelo J. Tension-band wiring for olecranon fractures: analysis of risk factors for failure. J Shoulder Elbow Surg. 2006 May-Jun;15(3):351-6. doi: 10.1016/j.jse.2005.08.002.

  PMID: 16679238 BACKGROUND

• Macko D, Szabo RM. Complications of tension-band wiring of olecranon fractures. J Bone Joint Surg Am. 1985 Dec;67(9):1396-401.

  PMID: 3908460 BACKGROUND

• Horne JG, Tanzer TL. Olecranon fractures: a review of 100 cases. J Trauma. 1981 Jun;21(6):469-72.

  PMID: 7230301 BACKGROUND

• Newman SD, Mauffrey C, Krikler S. Olecranon fractures. Injury. 2009 Jun;40(6):575-81. doi: 10.1016/j.injury.2008.12.013. Epub 2009 Apr 23.

  PMID: 19394931 BACKGROUND

• Gartsman GM, Sculco TP, Otis JC. Operative treatment of olecranon fractures. Excision or open reduction with internal fixation. J Bone Joint Surg Am. 1981 Jun;63(5):718-21.

  PMID: 7240294 BACKGROUND

• Parker MJ, Richmond PW, Andrew TA, Bewes PC. A review of displaced olecranon fractures treated conservatively. J R Coll Surg Edinb. 1990 Dec;35(6):392-4.

  PMID: 2086804 BACKGROUND

• Veras Del Monte L, Sirera Vercher M, Busquets Net R, Castellanos Robles J, Carrera Calderer L, Mir Bullo X. Conservative treatment of displaced fractures of the olecranon in the elderly. Injury. 1999 Mar;30(2):105-10. doi: 10.1016/s0020-1383(98)00223-x.

  PMID: 10476278 BACKGROUND

Study Officials

• Margaret M McQueen, MD, FRCSEd

  Edinburgh Orthopaedic Trauma Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: StR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)