Pertrochanter Arthroplasty Versus Osteosynthesis (PAVO)
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|ClinicalTrials.gov Identifier: NCT02171897|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : September 4, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|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|
|Experimental: Patients treated with osteosynthesis||
|Experimental: Patients treated with total hip replacement||
Procedure: Total hip replacement
- Harris Score [ Time Frame: At 6 months after surgery ]Functional hip score
- PMA functional score [ Time Frame: Up to 1 year after surgery ]Functional score
- Time to recovery of weight-bearing [ Time Frame: Up to 1 year after surgery ]
- Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking) [ Time Frame: Up to 1 year after surgery ]
- Parker score [ Time Frame: Up to 1 year after surgery ]Score autonomy
- Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism) [ Time Frame: Up to 1 year after surgery ]
- Death rate [ Time Frame: Up to 1 year after surgery ]
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
|CHU de DIJON|
|Dijon, France, 21079|