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

Not Applicable

• Conditions: Total Hip Arthroplasty
• Interventions: Device: radiostereometric analysis (RSA)

• Registration Number: NCT02525770
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetabular liner in N2VAC® conventional polyethylene	radiostereometric analysis (RSA)	hip replacement with acetabular liner in N2VAC® conventional polyethylene
acetabular liner in X3 polyethylene	radiostereometric analysis (RSA)	acetabular in X3 polyethylene

Primary Outcome Measures

Name	Time	Method
Penetration of the femoral head in the polyethylene measure in millimeters	change over baseline and 2 years	The median head penetration in millimeters

Trial Locations

Locations (1)

Département d'orthopédie traumatologie, CHu de Caen; 🇫🇷 Caen, France