A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Condition(s) targeted: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biomet Orthopedics, Inc.

Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Clinical Research, Biomet Orthopedics, Inc.

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

Official title: A Prospective, Non-Controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Study design: Cohort, Prospective

Primary outcome: Incidence of revisions and removals assessed by the use of a yearly survey mail to patient

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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, unmanagable by other techniques

- Revision of previously failed total hip arthroplasty

- Uncemented applicaitons

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

Starting date: January 2006
Ending date: April 2018
Last updated: June 13, 2008