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Pertrochanter Arthroplasty Versus Osteosynthesis (PAVO)

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ClinicalTrials.gov Identifier: NCT02171897
Recruitment Status : Unknown
Verified May 2014 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.

The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.

The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.


Condition or disease Intervention/treatment Phase
Pertrochanter Fracture Procedure: Osteosynthesis Procedure: Total hip replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: Patients treated with osteosynthesis Procedure: Osteosynthesis
Experimental: Patients treated with total hip replacement Procedure: Total hip replacement



Primary Outcome Measures :
  1. Harris Score [ Time Frame: At 6 months after surgery ]
    Functional hip score


Secondary Outcome Measures :
  1. PMA functional score [ Time Frame: Up to 1 year after surgery ]
    Functional score

  2. Time to recovery of weight-bearing [ Time Frame: Up to 1 year after surgery ]
  3. Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking) [ Time Frame: Up to 1 year after surgery ]
  4. Parker score [ Time Frame: Up to 1 year after surgery ]
    Score autonomy

  5. Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism) [ Time Frame: Up to 1 year after surgery ]
  6. Death rate [ Time Frame: Up to 1 year after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients who have provided written informed consent
  • Patients over 18 years old
  • Patients less than 70 years old
  • Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)

Exclusion Criteria:

  • Adult under guardianship
  • Patients not covered by national health insurance
  • Pregnant or breast-feeding women
  • Unable to walk independently before the trauma
  • Patients with dementia

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): NCT02171897


Contacts
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Contact: Ludovic LABATTUT 3 80 29 33 74 ext +33 ludovic.labattut@chu-dijon.fr

Locations
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France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Ludovic LABATTUT    3 80 29 33 74 ext +33    ludovic.labattut@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02171897     History of Changes
Other Study ID Numbers: TREMLET AOI 2013
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: May 2014