Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Terminated

• Conditions: Osteoarthritis
• Interventions: Device: BiHapro hip stem with PPS Ti+BoneMaster HA; Device: BiHapro hip stem with PPS Ti+Plasma HA

• Registration Number: NCT00755001
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with BoneMaster HA	BiHapro hip stem with PPS Ti+BoneMaster HA	BiHapro Hip stem with PPS Ti + BoneMaster HA
with Plasma HA	BiHapro hip stem with PPS Ti+Plasma HA	BiHapro Hip stem with PPS Ti + Plasma HA

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	annual at least to 5 yr

Secondary Outcome Measures

Name	Time	Method
Radiographic Assessment	Annual; At least to 5 yr

Trial Locations

Locations (2)

University Central Hospital of Asturias; 🇪🇸 Oviedo, Spain

University Hospital of Aviles; 🇪🇸 Aviles, Spain