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Trial record 41 of 200 for:    Louisville AND placed

E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads

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ClinicalTrials.gov Identifier: NCT01943149
Recruitment Status : Active, not recruiting
First Posted : September 16, 2013
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Renovis Surgical Technologies, Inc.

Brief Summary:
The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.

Condition or disease
In Need of a Total Hip Arthroplasty

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
Study Start Date : January 2014
Estimated Primary Completion Date : January 2024



Primary Outcome Measures :
  1. E-Max liner wear rate [ Time Frame: Change from baseline to 10 years post-operative ]
    This measure's purpose it to look at the longevity of our product. Radiographs will be taken at standard checkpoints over the course of 10 years. Radiographic analysis will be done to assess wear rates of the E-Max liner over the course of the 10 year study. Wear rates will then be compared to other products that have already been studied and published in hopes of finding that E-Max's wear rates are at least as good if not better than comparative products on the market.


Secondary Outcome Measures :
  1. Patient Function and Mobility [ Time Frame: Change from Pre-operative to 10 years post-operative ]
    This measure will assess patient function and mobility preoperatively and compare this at standard checkpoints over 10 years post-operatively. This will be done through use of the Harris Hip Score and UCLA Functional Assessment with the hope of seeing improvement in both over the course of time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.
Criteria

Inclusion Criteria:

  • Patient is under 65 years of age
  • Patient's health status qualifies as ASA 1 or ASA 2
  • Patient is willing to commit to long term follow (study duration is 10 yrs)

Exclusion Criteria:

  • Allergy to any materials used in hip implant
  • Unwillingness to participate in long term follow-up
  • Diagnosis of inflammatory arthritis
  • Simultaneous bilateral total hip arthroplasty is recommended.
  • Patient's health status qualifies as ASA 3 or greater.
  • Patient is over the age of 65 of age

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): NCT01943149


Locations
United States, Colorado
Cornerstone Orthopedics
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Renovis Surgical Technologies, Inc.

Responsible Party: Renovis Surgical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01943149     History of Changes
Other Study ID Numbers: HIP-001
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015