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Pertrochanter Arthroplasty Versus Osteosynthesis (PAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02171897
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : September 4, 2019
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)
Actual 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
Actual Study Start Date : January 29, 2015
Actual Primary Completion Date : October 21, 2018
Actual Study Completion Date : October 21, 2018

Resource links provided by the National Library of Medicine

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

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 identifier (NCT number): NCT02171897

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Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT02171897     History of Changes
Other Study ID Numbers: TREMLET AOI 2013
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries