Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis
This trial is active, not recruiting.
|Condition||total hip arthroplasty|
|Treatment||radiostereometric analysis (rsa)|
|Sponsor||University Hospital, Caen|
|Start date||June 2010|
|End date||July 2016|
|Trial size||112 participants|
|Trial identifier||NCT02525770, 09-018|
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.
The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.
|Intervention model||parallel assignment|
|Primary purpose||basic science|
acetabular in X3 polyethylene
hip replacement with acetabular liner in N2VAC® conventional polyethylene
Penetration of the femoral head in the polyethylene measure in millimeters
time frame: change over baseline and 2 years
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement Exclusion Criteria: - Patient aged 71 or more - Pregnant woman or wishing to be for the duration of the study - Resumption of total hip replacement, or cephalic prosthesis cups - Primary or secondary malignant neoplasm of the hip - Protected adult patient
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