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Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Sponsor
Zimmer Biomet (Industry)
Overall Status
Terminated
CT.gov ID
NCT00755001
Collaborator
Biomet Spain Orthopaedics S.L. (Industry)
40
Enrollment
2
Locations
48
Duration (Months)
20
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.

Condition or Disease Intervention/Treatment Phase
  • Device: BiHapro hip stem with PPS Ti+Plasma HA
  • Device: BiHapro hip stem with PPS Ti+BoneMaster HA

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.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Study on BiHapro Total Hip System With Different Surface Coatings
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • BiHapro hip stem

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Harris Hip Score [annual at least to 5 yr]

    Secondary Outcome Measures

    1. Radiographic Assessment [Annual; At least to 5 yr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 University Hospital of Aviles Aviles Spain
    2 University Central Hospital of Asturias Oviedo Spain

    Sponsors and Collaborators

    • Zimmer Biomet
    • Biomet Spain Orthopaedics S.L.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT00755001
    Other Study ID Numbers:
    • BMET EP 01
    First Posted:
    Sep 18, 2008
    Last Update Posted:
    Jul 7, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Zimmer Biomet
    Total Hip Replacement
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Jul 7, 2017