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A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00698152
Recruitment Status : Unknown
Verified June 2015 by Zimmer Biomet ( Biomet Orthopedics, LLC ).
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2008
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

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

Condition or disease
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

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 Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Study Start Date : January 2006
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Group/Cohort
ArComXL® polyethylene
ArComXL® polyethylene



Primary Outcome Measures :
  1. Incidence of revisions and removals assessed by the use of a yearly survey mail to patient [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698152


Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Russell Schenck, PhD Clinical Research, Biomet Orthopedics, Inc.

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00698152     History of Changes
Other Study ID Numbers: ORTHO.CR.H012
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Total Hip Arthroplasty
Total Hip Replacement
Hip Arthritis
Polyethylene

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes