Clinical Study on BiHapro Total Hip System With Different Surface Coatings

This study is currently recruiting participants.

Verified by Biomet, Inc., January 2010

First Received: September 16, 2008 Last Updated: January 7, 2010 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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

No publications provided

Responsible Party:	Biomet Spain Orthopaedics S.L. ( Jose Manuel Tevar )
Study ID Numbers:	BMET EP 01
Study First Received:	September 16, 2008
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00755001 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Biomet, Inc.:

Total Hip Replacement

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2010