Clinical Study on BiHapro 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
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. 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 BiHapro 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 BiHapro Total Hip System With Different Surface Coatings
Study design: Cohort, Prospective
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 of Aviles, Aviles, Spain; Recruiting
Daniel Hernandez Vaquero, MD
Daniel Hernandez Vaquero, MD, Principal Investigator
University Central Hospital of Asturias, Oviedo, Spain; Recruiting
Jose Paz, MD
Jose Paz, MD, Principal Investigator
Additional Information
Starting date: May 2007
Ending date: May 2015
Last updated: June 18, 2009
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