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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. (see Contacts and Locations)
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
  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:


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
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: 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:
Ankle Fractures
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 19, 2014