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

This study is currently recruiting participants.
Verified December 2012 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01758796
First received: December 26, 2012
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
ER-stress Positive Unimalleolar Fibula Fracture
Procedure: Non-operative treatment
Procedure: Operative treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

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 ]
    questionnaire

  • Olerud-Molander Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    questionnaire

  • Fracture healing [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Fracture healing is monitored in every study visits: 2, 6 and 12 weeks and 2 years after injury.


Secondary Outcome Measures:
  • Ankle joint movement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A Physiotherapist measure ankle joint dorsal- and plantarflexion.


Other Outcome Measures:
  • Talocrural joint congruence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 126
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Harri J Pakarinen, MD, PhD Oulu University Hospital
Principal Investigator: Tero HJ Kortekangas, MD Oulu University Hospital
  More Information

No publications provided

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
Study First Received: December 26, 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 positive
Unimalleolar fibula fracture
Operative vs non-operative treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014