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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
(Active Comparator)
acetabular in X3 polyethylene
radiostereometric analysis (rsa)
(Active Comparator)
hip replacement with acetabular liner in N2VAC® conventional polyethylene
radiostereometric analysis (rsa)

Primary Outcomes

Penetration of the femoral head in the polyethylene measure in millimeters
time frame: change over baseline and 2 years

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Caen.