Clinical Study on BiMetric Total Hip System With Different Surface Coatings
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Hip Replacement with BiMetric Hip Stem (Device); Hip Replacement with BiMetric Hip stem (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Garcia Alonso, MD, Principal Investigator, Affiliation: University Hospital of Valladolid
Overall contact:
Jose Manuel Tevar, Phone: +34 91 721 63 30, Email: josemanuel.tevar@biomet.es
Summary
This post market study intends to evaluate the safety and the performance of BiMetric Total
Hip System with two types of coatings.
The efficacy of the prosthesis will be evaluated comparing the pain, the function and the
range of motion measured preoperatively and postoperatively using recognized clinical
outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure
the mineral bony thickness in the areas of Gruen zones of the proximal femur.
Clinical Details
Official title: Clinical Study on BiMetric Total Hip System With Different Surface Coatings
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Harris Hip Score
Secondary outcome: Radiographic Assessment
Eligibility
Minimum age: N/A.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
The patients who are selected for this study must fit the following criteria.
- Candidate for a Total Hip Arthroplasty
- Less than 80 years of age.
- A pre-operative level of pain and function the same as for conventional joint
replacement.
- A likelihood of obtaining relief of pain and improved function.
- Full skeletal maturity.
- Ability to follow instructions.
- Good general health for age.
- Willing to return for follow-up evaluations.
- No bias to sex.
Locations and Contacts
Jose Manuel Tevar, Phone: +34 91 721 63 30, Email: josemanuel.tevar@biomet.es
University Hospital Rio Ortega, Valladolid, Spain
Additional Information
Starting date: June 2009
Ending date: May 2019
Last updated: June 18, 2009
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