A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Completed

• Conditions: Avascular Necrosis; Rheumatoid Arthritis; Osteoarthritis

• Registration Number: NCT00698152
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2006-01-23
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2016-01-15
• Study Completion: 2016-01-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of revisions and removals	Annually through 10 years	Patient questionnaire

Trial Locations

Locations (5)

The Orthopaedic Institute of Ohio; 🇺🇸 Lima, Ohio, United States

The Orthopaedic Center; 🇺🇸 Rockville, Maryland, United States

Ohio Valley Orthopedic and Sports Medicine; 🇺🇸 West Chester, Ohio, United States

Scranton Orthopaedic Specialists, PC; 🇺🇸 Dickson City, Pennsylvania, United States

Texas Orthopedic Specialists, PA; 🇺🇸 Grapevine, Texas, United States