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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00698152
Other study ID # ORTHO.CR.H012
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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