Clinical trial NCT00698152: A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Official title: A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Keywords: Total Hip Arthroplasty
Total Hip Replacement
Hip Arthritis
Polyethylene
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of revisions and removals
timeFrame: Annually through 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: The Orthopaedic Center
state: Maryland
city: Lima
country: United States
facility: The Orthopaedic Institute of Ohio
state: Ohio
city: West Chester
country: United States
facility: Ohio Valley Orthopedic and Sports Medicine
state: Ohio
city: Dickson City
country: United States
facility: Scranton Orthopaedic Specialists, PC
state: Pennsylvania
city: Grapevine
country: United States
facility: Texas Orthopedic Specialists, PA
state: Texas
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, MBA
role: STUDY_DIRECTOR
References: