Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Zimmer Biomet40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis

Interventions

BiHapro hip stem with PPS Ti+Plasma HADEVICE

BiHapro hip stem with PPS Ti+Plasma HA

BiHapro hip stem with PPS Ti+BoneMaster HADEVICE

BiHapro hip stem with PPS Ti+BoneMaster HA

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

University Hospital of Aviles

Avilés, Spain

University Central Hospital of Asturias

Oviedo, Spain

Outcomes

Primary Outcomes

Harris Hip Score

Time frame: annual at least to 5 yr

Secondary Outcomes

Radiographic Assessment

Time frame: Annual; At least to 5 yr

Data from ClinicalTrials.gov

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