A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698152
• Other study ID #: ORTHO.CR.H012
• Status: Completed
• Start date: January 23, 2006
• Est. completion date: January 15, 2016

Study information

• Verified date: March 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 15, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Scranton Orthopaedic Specialists, PC	Dickson City	Pennsylvania
United States	Texas Orthopedic Specialists, PA	Grapevine	Texas
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of revisions and removals	Patient questionnaire	Annually through 10 years