Clinical Study on BiHapro Total Hip System With Different Surface Coatings

NCT ID: NCT00755001

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with Plasma HA

BiHapro Hip stem with PPS Ti + Plasma HA

BiHapro hip stem with PPS Ti+Plasma HA

Intervention Type DEVICE

BiHapro hip stem with PPS Ti+Plasma HA

with BoneMaster HA

BiHapro Hip stem with PPS Ti + BoneMaster HA

BiHapro hip stem with PPS Ti+BoneMaster HA

Intervention Type DEVICE

BiHapro hip stem with PPS Ti+BoneMaster HA

Interventions

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BiHapro hip stem with PPS Ti+Plasma HA

BiHapro hip stem with PPS Ti+Plasma HA

Intervention Type DEVICE

BiHapro hip stem with PPS Ti+BoneMaster HA

BiHapro hip stem with PPS Ti+BoneMaster HA

Intervention Type DEVICE

Other Intervention Names

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BiHapro hip stem BiHapro hip stem

Eligibility Criteria

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Inclusion 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.
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet Spain Orthopaedics S.L.

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Aviles

Avilés, , Spain

Site Status

University Central Hospital of Asturias

Oviedo, , Spain

Site Status

Countries

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Spain

Other Identifiers

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BMET EP 01

Identifier Type: -

Identifier Source: org_study_id

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