Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Zimmer Biomet

Status: Terminated

Conditions: Osteoarthritis

Treatments: Device: BiHapro hip stem with PPS Ti+Plasma HA; Device: BiHapro hip stem with PPS Ti+BoneMaster HA

Study type: Observational

Funder types: Industry

Identifiers

NCT00755001

BMET EP 01

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

40 participants in 2 patient groups

with Plasma HA

Description:

BiHapro Hip stem with PPS Ti + Plasma HA

Treatment:

Device: BiHapro hip stem with PPS Ti+Plasma HA

with BoneMaster HA

Description:

BiHapro Hip stem with PPS Ti + BoneMaster HA

Treatment:

Device: BiHapro hip stem with PPS Ti+BoneMaster HA