Osteoarthritis
Conditions
Keywords
Total Hip Replacement
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.
Interventions
DEVICEBiHapro hip stem with PPS Ti+BoneMaster HA
BiHapro hip stem with PPS Ti+BoneMaster HA
DEVICEBiHapro hip stem with PPS Ti+Plasma HA
BiHapro hip stem with PPS Ti+Plasma HA
Sponsors
Biomet Spain Orthopaedics S.L.
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score | annual at least to 5 yr |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Assessment | Annual; At least to 5 yr |
Countries
Spain
Outcome results
None listed