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

NCT02525770 | Unknown

• 1 other identifier: 09-018
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Penetration of the femoral head in the polyethylene measure in millimeters

  The median head penetration in millimeters

  change over baseline and 2 years

Study Arms (2)

acetabular liner in X3 polyethylene

ACTIVE COMPARATOR

acetabular in X3 polyethylene

Device: radiostereometric analysis (RSA)

acetabular liner in N2VAC® conventional polyethylene

ACTIVE COMPARATOR

hip replacement with acetabular liner in N2VAC® conventional polyethylene

Device: radiostereometric analysis (RSA)

Interventions

radiostereometric analysis (RSA) DEVICE

acetabular liner in N2VAC® conventional polyethylene; acetabular liner in X3 polyethylene

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Département d'orthopédie traumatologie, CHu de Caen

Caen, 14000, France

Location

MeSH Terms

Interventions

Radiostereometric Analysis

Intervention Hierarchy (Ancestors)

Photogrammetry; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 17, 2015
• Study Start: June 1, 2010
• Primary Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

FR (1)