Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01787929 |
| Other study ID # |
12-PP-10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2016 |
| Est. completion date |
March 11, 2020 |
Study information
| Verified date |
April 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study was to identify the clinical relevance of cementless
hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of
cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the
relevance of cementless hemiarthroplasties in displaced femoral neck fractures.
150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented
hemiarthroplasty. They will be followed during one year after the surgery, with a
functionality assessment at 3 month and 12 month.
Description:
Most subcapital femoral neck fractures occur in the elderly population and are the result of
low-energy trauma. Return of the patient to prefracture level of function usually can best be
accomplished with surgery. Nonsurgical management has resulted in an excessive rate of
medical morbidity and mortality. The overall 1-year mortality rate after hip fracture in the
elderly ranges from 14% to 36%.
Prosthetic replacement has been favored for the treatment of displaced femoral neck fractures
in the frail, elderly population with multiple medical comorbidities because of the
challenges of achieving stable proximal fragment fixation in osteopenic bone, and the need
for early, full weight-bearing mobilization. Failure rates of 30% to 40% have been
consistently reported over multiple series over the past few decades in elderly patients with
displaced femoral neck fractures treated with internal fixation.
Once prosthetic arthroplasty has been chosen, further controversy surrounds the type of
fixation, cemented or cementless. Good to excellent results can be expected with either
cemented or cementless newer generation arthroplasties. Risks of cementless arthroplasty
include femoral fracture, prosthesis subsidence, and anterior thigh pain. Cementation of the
prosthesis places the patient at risk for intraoperative death or embolization of marrow
content during cementation.
The aim of the study is to assess the clinical relevance of a collared uncemented stem
compared with use of cemented stem in elderly population with displaced femoral neck
fracture.
A randomised trial will include 150 patients with an acute displaced femoral neck fracture in
an elderly population. All patient will give informed consent, and the research protocol is
approved by the regional ethics committee. The inclusion criteria are an age of at least 70
years old, a displaced femoral neck fracture (Garden stage III or IV), an ASA grade< 4,
ambulatory and non cognive impairment patients. Clinical and radiographic examinations will
be perform at perioperative period, at 3 and 12 month after surgery. The main outcome
measures will be functional score, pain, mobility, complications, reoperations, activity of
daily living, quality of life, strenght, and radiolographic subsidence.
The primary hypothesis of this study is that use of a collared uncemented stem would not
provide an improvement in functional outcome compared with use of cemented stem in elderly
population with displaced femoral neck fracture.
