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Clinical Study on BiHapro Total Hip System With Different Surface Coatings
This study is currently recruiting participants.
Verified by Biomet, Inc., September 2008
Sponsored by: Biomet, Inc.
Information provided by: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00755001
  Purpose

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.


Condition
Osteoarthritis

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: annual at least to 5 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic Assessment [ Time Frame: Annual; At least to 5 yr ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: May 2007
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
BiHapro Hip stem with PPS Ti + Plasma HA
2
BiHapro Hip stem with PPS Ti + BoneMaster HA

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Total Hip Arthroplasty

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755001

Contacts
Contact: Jose Manuel Tevar +34 91 721 63 30 josemanuel.tevar@biomet.es

Locations
Spain
University Hospital of Aviles Recruiting
Aviles, Spain
Contact: Daniel Hernandez Vaquero, MD            
Principal Investigator: Daniel Hernandez Vaquero, MD            
University Central Hospital of Asturias Recruiting
Oviedo, Spain
Contact: Jose Paz, MD            
Principal Investigator: Jose Paz, MD            
Sponsors and Collaborators
Biomet, Inc.
  More Information

Responsible Party: Biomet Spain Orthopaedics S.L. ( Jose Manuel Tevar )
Study ID Numbers: BMET EP 01
Study First Received: September 16, 2008
Last Updated: September 17, 2008
ClinicalTrials.gov Identifier: NCT00755001  
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Biomet, Inc.:
Total Hip Replacement

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 13, 2009



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