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A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698152
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

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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
Actual Study Start Date : January 23, 2006
Actual Primary Completion Date : January 15, 2016
Actual Study Completion Date : January 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Group/Cohort
ArComXL® polyethylene
ArComXL® polyethylene



Primary Outcome Measures :
  1. Incidence of revisions and removals [ Time Frame: Annually through 10 years ]
    Patient questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
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


Locations
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United States, Maryland
The Orthopaedic Center
Rockville, Maryland, United States, 20850
United States, Ohio
The Orthopaedic Institute of Ohio
Lima, Ohio, United States, 45804
Ohio Valley Orthopedic and Sports Medicine
West Chester, Ohio, United States, 45069
United States, Pennsylvania
Scranton Orthopaedic Specialists, PC
Dickson City, Pennsylvania, United States, 18519
United States, Texas
Texas Orthopedic Specialists, PA
Grapevine, Texas, United States, 76051
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, MBA Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00698152    
Other Study ID Numbers: ORTHO.CR.H012
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Keywords provided by Zimmer Biomet:
Total Hip Arthroplasty
Total Hip Replacement
Hip Arthritis
Polyethylene
Additional relevant MeSH terms:
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Arthritis
Necrosis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes