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

Total Hip Arthroplasty Clinical Trial

— COCYCOX  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02525770
• Other study ID #: 09-018
• Status: Active, not recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: July 27, 2016
• Start date: June 2010

Study information

• Verified date: July 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• radiostereometric analysis (RSA)

Locations

Country	Name	City	State
France	Département d'orthopédie traumatologie, CHu de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration of the femoral head in the polyethylene measure in millimeters	The median head penetration in millimeters	change over baseline and 2 years	No