Clinical Study on BiHapro Total Hip System With Different Surface Coatings

This study has been terminated.
(The site decided to stop the study)
Sponsor:
Collaborator:
Biomet Spain Orthopaedics S.L.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00755001
First received: September 16, 2008
Last updated: February 29, 2012
Last verified: February 2012
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 29, 2012
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 September 18, 2014