Pertrochanter Fracture Clinical Trial
— PAVOOfficial title:
Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
| Verified date | September 2019 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | October 21, 2018 |
| Est. primary completion date | October 21, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 70 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de DIJON | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Harris Score | Functional hip score | At 6 months after surgery | |
| Secondary | PMA functional score | Functional score | Up to 1 year after surgery | |
| Secondary | Time to recovery of weight-bearing | Up to 1 year after surgery | ||
| Secondary | Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking) | Up to 1 year after surgery | ||
| Secondary | Parker score | Score autonomy | Up to 1 year after surgery | |
| Secondary | Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism) | Up to 1 year after surgery | ||
| Secondary | Death rate | Up to 1 year after surgery |