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Study of Operative Versus Non-operative Treatment of ER-stress Positive Ankle Fractures

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ClinicalTrials.gov Identifier: NCT01758796
Recruitment Status : Recruiting
First Posted : January 1, 2013
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu

Brief Summary:
The purpose of the study is to find the optimal treatment for ER-Stress positive Weber-B unimallaolar ankle fractures.

Condition or disease Intervention/treatment Phase
Lateral Malleolus Fracture Procedure: Non-operative treatment Procedure: Operative treatment Not Applicable

Detailed Description:
Prospective randomized controlled comparative study of non-operative vs operative treatment of ER-stress positive unimalleolar ankle fractures. The ER-stress test is performed by consultant trauma orthopedic surgeon or a trauma resident with trauma service done. Medial clear space opening of 5mm or more was considered a positive ER stress test. Those patients were randomized either non-operative or operative treatment by opening the sealed envelope.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of Operative Versus Non-operative Treatment of ER-stress Positive Weber-B Unimalleolar Fractures.
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Non-operative treatment
Non-operative treatment: 6 weeks in a cast, 4 weeks partial weight bearing and last 2 weeks weight bearing as tolerated.
Procedure: Non-operative treatment
6 weeks in a cast. 4 weeks with partial weight bearing and last 2 weeks weight bearing as tolerated.
Active Comparator: Operative treatment
ORIF, after care like in a non-operative treatment group.
Procedure: Operative treatment
Open reduction and osteosynthesis with semi-tubular plate and cortical screws.



Primary Outcome Measures :
  1. Olerud-Molander Score [ Time Frame: 2 years ]
    Ankle functional outcome questionnaire


Secondary Outcome Measures :
  1. FAOS [ Time Frame: 2 years ]
    Foot and Ankle Outcome Socre

  2. RAND 36 Health Item Survey [ Time Frame: 2 years ]
    Quality of life questinnaire

  3. VAS [ Time Frame: 2 years ]
    Visual Analogue Scale pain and function

  4. Fracture healing [ Time Frame: 2 years ]
  5. Ankle joint movement [ Time Frame: 2 years ]
    Research physiotherapist measures ankle dorsi- and plantarflexion


Other Outcome Measures:
  1. Talocrural joint congruence [ Time Frame: 2 years ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weber B unimalleolar ankle fracture
  • Age: 16 years or older
  • Voluntary
  • Operated within 7 days of the trauma
  • Walking without aid before accident

Exclusion Criteria:

  • Peripheral neuropathy
  • Pilon fracture
  • Bilateral ankle fracture
  • Simultaneous crural fracture
  • Pathological fracture
  • Active infection around the ankle
  • A previous ankle fracture or significant medial ligament trauma
  • Lives outside our hospital district or a foreigner
  • Co-operation is insufficient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758796


Contacts
Contact: Harri J Pakarinen, MD, PhD +3583152806 harri.pakarinen@ppshp.fi
Contact: Tero HJ Kortekangas, MD +3583155995 tero.kortekangas@ppshp.fi

Locations
Finland
OYS, Oulu university hospital, Department of orthopedic and traumatology Recruiting
Oulu, Pohjois-Pohjanmaa, Finland, 90100
Contact: Harri J Pakarinen, MD, PhD    +3583152806    harri.pakarinen@ppshp.fi   
Contact: Tero HJ Kortekangas, MD    +3583155995    tero.kortekangas@ppshp.fi   
Sub-Investigator: Iikka P Lantto, MD         
Sponsors and Collaborators
University of Oulu
Tampere University Hospital
Investigators
Study Director: Harri J Pakarinen, MD, PhD Oulu University Hospital
Principal Investigator: Tero HJ Kortekangas, MD Oulu University Hospital

Responsible Party: Harri Pakarinen, Orthopedic surgeon, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01758796     History of Changes
Other Study ID Numbers: OYSrct-Ankle3.2
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Harri Pakarinen, University of Oulu:
ER-stress positive
Unimalleolar fibula fracture
Operative vs non-operative treatment

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries