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

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Device: radiostereometric analysis (RSA)

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Département d'orthopédie traumatologie, CHu de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acetabular liner in X3 polyethylene; acetabular in X3 polyethylene	Device: radiostereometric analysis (RSA)
Active Comparator: acetabular liner in N2VAC® conventional polyethylene; hip replacement with acetabular liner in N2VAC® conventional polyethylene	Device: radiostereometric analysis (RSA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration of the femoral head in the polyethylene measure in millimeters	The median head penetration in millimeters	change over baseline and 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 09-018