A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00698152

Enrollment

149

Registered

2008-06-17

Start date

2006-01-23

Completion date

2016-01-15

Last updated

2020-03-30

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

Conditions

Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis

Keywords

Total Hip Arthroplasty, Total Hip Replacement, Hip Arthritis, Polyethylene

Brief summary

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Detailed description

Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected. This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid Arthritis * Correction of Functional Deformity * Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed total hip arthroplasty * Uncemented applications

Exclusion criteria

Absolute contraindications * Infection, sepsis and osteomyelitis Relative contraindications * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Osteoporosis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may be spread to the implant site * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy or neuromuscular disease

Design outcomes

Primary

Measure	Time frame	Description
Incidence of revisions and removals	Annually through 10 years	Patient questionnaire

Countries

United States

Outcome results