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:
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: June 2, 2015
Last verified: June 2015
  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
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:
  • Olerud-Molander score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Ankle functional outcome measure


Secondary Outcome Measures:
  • FAOS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Foot and Ankle Outcome Score

  • VAS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Visual Analogue Scale pain and function

  • RAND 36 Health item survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of life measurement

  • Fracture healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated 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
Active Comparator: Cast 3 weeks
Below-the-knee cast (glass fiber)
Other: Cast 3 weeks
Active Comparator: Cast 6 weeks
Below-the-knee cast (glass fiber)
Other: Cast 6 weeks

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

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

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
  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: June 2, 2015
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 September 02, 2015