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

Caen University Hospital

Status: Unknown

Conditions: Total Hip Arthroplasty

Treatments: Device: radiostereometric analysis (RSA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02525770

09-018

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

acetabular liner in X3 polyethylene

Active Comparator group

Description:

acetabular in X3 polyethylene

Treatment:

Device: radiostereometric analysis (RSA)

acetabular liner in N2VAC® conventional polyethylene

Active Comparator group

Description:

hip replacement with acetabular liner in N2VAC® conventional polyethylene

Treatment:

Device: radiostereometric analysis (RSA)