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PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758835
First Posted: January 1, 2013
Last Update Posted: September 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
  Purpose
PRCT 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. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Condition Intervention
Lateral Malleolus Fractures Other: Splint 3 weeks Other: Cast 3 weeks Other: Cast 6 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Harri Pakarinen, University of Oulu:

Primary Outcome Measures:
  • Olerud-Molander score [ Time Frame: 1 year ]
    Ankle functional outcome measure


Secondary Outcome Measures:
  • FAOS [ Time Frame: 1 year ]
    Foot and Ankle Outcome Score

  • VAS [ Time Frame: 1 year ]
    Visual Analogue Scale pain and function

  • RAND 36 Health item survey [ Time Frame: 1 year ]
    Quality of life measurement

  • Fracture healing [ Time Frame: 1 year ]

Estimated Enrollment: 246
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Splint 3 weeks
Removable ankle brace/splint
Other: Splint 3 weeks
A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.
Active Comparator: Cast 3 weeks
Below-the-knee cast (glass fiber)
Other: Cast 3 weeks
A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.
Active Comparator: Cast 6 weeks
Below-the-knee cast (glass fiber)
Other: Cast 6 weeks
standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.

Detailed Description:
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. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01758835


Locations
Finland
OYS, kirurgian klinkka, Oulu
Oulu, Finland, 90100
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
  More Information

Responsible Party: Harri Pakarinen, Orthopedic surgeon, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01758835     History of Changes
Other Study ID Numbers: OYSrctAnkle5
First Submitted: December 21, 2012
First Posted: January 1, 2013
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action