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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 November 23, 2014