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Clinical Trials/NCT02525770
NCT02525770
Unknown
Not Applicable

Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis

University Hospital, Caen1 site in 1 country112 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
University Hospital, Caen
Enrollment
112
Locations
1
Primary Endpoint
Penetration of the femoral head in the polyethylene measure in millimeters
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Penetration of the femoral head in the polyethylene measure in millimeters

Time Frame: change over baseline and 2 years

The median head penetration in millimeters

Study Sites (1)

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