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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02525770
Acronym
COCYCOX
Enrollment
112
Registered
2015-08-17
Start date
2010-06-30
Completion date
Unknown
Last updated
2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

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.

Interventions

DEVICEradiostereometric analysis (RSA)

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Penetration of the femoral head in the polyethylene measure in millimeterschange over baseline and 2 yearsThe median head penetration in millimeters

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026