Status:
TERMINATED
Clinical Study on BiHapro Total Hip System With Different Surface Coatings
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Biomet Spain Orthopaedics S.L.
Conditions:
Osteoarthritis
Eligibility:
All Genders
Up to 80 years
Brief Summary
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.
Detailed Description
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 Scor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00755001
Start Date
May 1 2007
End Date
May 1 2011
Last Update
July 7 2017
Active Locations (2)
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1
University Hospital of Aviles
Avilés, Spain
2
University Central Hospital of Asturias
Oviedo, Spain