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Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Multicenter Trial

This study is currently recruiting participants.
Verified December 2012 by University of Oulu
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01758835
First received: December 21, 2012
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Guestionnaires: RAND-36, VAS, Olerud-Molander and FAOS in follow up-visits 6 and 12 weeks and 1 and 2 year.


Condition Intervention
ER-stress-test Negative Unimalleolar Fibula Weber-B Fractures
 Other: Splint 3 weeks
Other: Cast 3 weeks
Other: Cast 6 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • RAND-36 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • FAOS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • VAS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Olerud-Molander [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fracture healing [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Splint 3 weeks Other: Splint 3 weeks
Active Comparator: Cast 3 weeks Other: Cast 3 weeks
Active Comparator: Cast 6 weeks Other: Cast 6 weeks

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stable Weber-B type fibula fracture
  • ER-stress negative
  • 16 or over years old
  • Willingness to participate on study proved by a signature and date
  • Walking without aid before accident
  • Treatment started within 7 days from injury

Exclusion Criteria:

  • Prior ankle fracture or significant fracture in the area of ankle or leg
  • Bilateral ankle fracture
  • Pathological fracture
  • Diabetes mellitus or an other significant periferial neuropathy
  • municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
  • Patient's understanding or co-operation inadequate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758835

Contacts
Contact: Harri Juhani Pakarinen, MD, PhD +35883152806 harri.pakarinen@ppshp.fi
Contact: Tero Heikki Juhana Heikki Kortekangas, MD +3583155995 tero.kortekangas@ppshp.fi

Locations
Finland
OYS, kirurgian klinkka, Oulu Recruiting
Oulu, Finland, 90100
Contact: Harri Juhani Pakarinen, MD, Phd     +35883152806     harri.pakarinen@ppshp.fi    
Contact: Tero Heikki Juhana Kortekangas, MD     +35883152011     tero.kortekangas@ppshp.fi    
Sponsors and Collaborators
University of Oulu
Tampere University Hospital
Investigators
Study Director: Harri Juhani Pakarinen, MD, PhD Oulu University Hospital
  More Information

No publications provided

Responsible Party: Harri Pakarinen, Orthopedic surgeon, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01758835     History of Changes
Other Study ID Numbers: OYSrctAnkle5
Study First Received: December 21, 2012
Last Updated: December 31, 2012
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Keywords provided by University of Oulu:
ER-stress-test negative
unimalleolar
fibula
Weber-B fractures

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013