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OpenTrials
Completed

NCT Number: NCT02171897

Pertrochanter Arthroplasty Versus Osteosynthesis

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.

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Key information

Conditions

Pertrochanter Fracture

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteosynthesis

Procedure

Total hip replacement

Procedure

Primary outcomes

  1. Harris Score

    Time frame: At 6 months after surgery

    Functional hip score

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing

Acronym: PAVO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.