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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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acetabular liner in X3 polyethylene

acetabular in X3 polyethylene

Group Type ACTIVE_COMPARATOR

radiostereometric analysis (RSA)

Intervention Type DEVICE

acetabular liner in N2VAC® conventional polyethylene

hip replacement with acetabular liner in N2VAC® conventional polyethylene

Group Type ACTIVE_COMPARATOR

radiostereometric analysis (RSA)

Intervention Type DEVICE

Interventions

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radiostereometric analysis (RSA)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No