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Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture (PET)

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ClinicalTrials.gov Identifier: NCT02788994
Recruitment Status : Unknown
Verified March 2017 by PeterGiannoudis, University of Leeds.
Recruitment status was:  Recruiting
First Posted : June 2, 2016
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Citieffe S.r.l
Information provided by (Responsible Party):
PeterGiannoudis, University of Leeds

Brief Summary:

This is a preliminary study to establish the issues and potential of the investigators proposed project, which involves recruitment of patients with and without dementia, who have been admitted to hospital following hip fractures. The study will be evaluating the result of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored leading to their independence. These patients would require surgical fixation (not replacement) of their hip fractures.

The study will evaluate two methods of fixation of hip fractures treated with either a pin (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate which is applied on the outer aspect of the thigh bone.

The data collected from this study will provide information on whether one method of fixation is better than the other.


Condition or disease Intervention/treatment Phase
Unilateral Unstable Hip Device: Endovis BA2 nail Device: Dynamic Hip Screw (DHS) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcome Following Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture With Either the Endovis BA2 Cephalomedullary Nail or the Dynamic Hip Screw: A Single Centre, Feasibility Study
Study Start Date : June 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovis BA2 Nail

The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments.

The system has been designed to allow:

  • stable fracture synthesis for fast rehabilitation and early mobilization
  • an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps)

This is a one off surgical fixation.

Device: Endovis BA2 nail

The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments.

The system has been designed to allow:

  • stable fracture synthesis for fast rehabilitation and early mobilization
  • an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps)

Active Comparator: Dynamic Hip Screw (DHS)

The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation.

This Dynamic Hip Screw method is currently used and is a one off surgical fixation.

Device: Dynamic Hip Screw (DHS)

The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation.

This Dynamic Hip Screw method is currently used and is a one off surgical fixation.





Primary Outcome Measures :
  1. All patients attending week 4 follow-up visit must be able to perform the TUG test at least once. [ Time Frame: 4 weeks ]
    The TUG test involves standing up from a seated position, walking three metres, turning around, and then walking three metres back to chair and returning to the seated position. The TUG times will be noted down in seconds/ minutes.


Secondary Outcome Measures :
  1. The length of hospital stay for each patient [ Time Frame: Average of 20 days ]
    Measure against the average of 20 days hospital stay after operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 55-95 years
  • Fresh unstable (AO/OTA type A2) pertrochanteric fracture
  • If medically fit, patient will undergo surgical fixation within 48 hours of admission. Otherwise, all patients to be recruited must undergo surgery within 7 days of admission
  • Patient or patient's carer/personal or nominated consultee has provided informed consent/assent to participate in the study
  • Patient is considered able to complete the study assessment and visit schedule in the opinion of the investigating team

Exclusion Criteria:

  • Unable to ambulate pre-injury, even with walking aids
  • Unable to undergo surgical fixation within 7 days of admission
  • Patient is for any reason considered unable to carry out the required study assessments or complete the follow-up visit schedule, in the opinion of the investigating team
  • Previous stroke (non-recovered)
  • Recent myocardial infarction (up to 60 days)
  • Presence of fracture(s) in contralateral leg
  • Presence of fracture(s) in ipsilateral leg, in addition to the pertrochanteric hip fracture
  • Known renal or hepatic failure as defined by:

    • Elevated transaminases ≥ 2.0 x upper limits of normal for:

      • Serum aspartate aminotransferase (AST)
      • Serum alanine aminotransferase (ALT)
    • Significantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation21

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): NCT02788994


Contacts
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Contact: Peter Giannoudis, MBBS,CCST,MD 01133922750 peter.giannoudis@nhs.net

Locations
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United Kingdom
University of Leeds Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 2LU
Contact: Bernadette Cook    0113 39 22334    bernadette.cook@nhs.net   
Contact: Peter Giannoudis    0113 3922750      
Sponsors and Collaborators
University of Leeds
Citieffe S.r.l
Investigators
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Principal Investigator: Peter Giannoudis, MBBS,CCST,MD University of Leeds

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Responsible Party: PeterGiannoudis, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT02788994     History of Changes
Other Study ID Numbers: OR15/280
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries