Pertrochanter Arthroplasty Versus Osteosynthesis
PAVO
Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedStudy Start
First participant enrolled
January 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2018
CompletedSeptember 4, 2019
September 1, 2019
3.7 years
June 18, 2014
September 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Harris Score
Functional hip score
At 6 months after surgery
Secondary Outcomes (6)
PMA functional score
Up to 1 year after surgery
Time to recovery of weight-bearing
Up to 1 year after surgery
Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking)
Up to 1 year after surgery
Parker score
Up to 1 year after surgery
Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism)
Up to 1 year after surgery
- +1 more secondary outcomes
Study Arms (2)
Patients treated with osteosynthesis
EXPERIMENTALPatients treated with total hip replacement
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de DIJON
Dijon, 21079, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 24, 2014
Study Start
January 29, 2015
Primary Completion
October 21, 2018
Study Completion
October 21, 2018
Last Updated
September 4, 2019
Record last verified: 2019-09