Clinical Study on BiHapro Total Hip System With Different Surface Coatings

This study has been terminated.

( The site decided to stop the study )

First Received on September 16, 2008. Last Updated on December 2, 2011 History of Changes

Sponsor:	Biomet, Inc.
Collaborator:	Biomet Spain Orthopaedics S.L.
Information provided by (Responsible Party):	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.

Condition	Intervention
Osteoarthritis	Device: BiHapro hip stem with PPS Ti+Plasma HA Device: BiHapro hip stem with PPS Ti+BoneMaster HA

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: 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 ]

Enrollment:	40
Study Start Date:	May 2007
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
with Plasma HA BiHapro Hip stem with PPS Ti + Plasma HA	Device: BiHapro hip stem with PPS Ti+Plasma HA BiHapro hip stem with PPS Ti+Plasma HA Other Name: BiHapro hip stem
with BoneMaster HA BiHapro Hip stem with PPS Ti + BoneMaster HA	Device: BiHapro hip stem with PPS Ti+BoneMaster HA BiHapro hip stem with PPS Ti+BoneMaster HA Other Name: BiHapro hip stem

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 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.

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

Locations

Spain
University Hospital of Aviles
Aviles, Spain
University Central Hospital of Asturias
Oviedo, Spain

Sponsors and Collaborators

Biomet, Inc.

Biomet Spain Orthopaedics S.L.

More Information

No publications provided

Responsible Party:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00755001 History of Changes
Other Study ID Numbers:	BMET EP 01
Study First Received:	September 16, 2008
Last Updated:	December 2, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Biomet, Inc.:

Total Hip Replacement

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012