Trials / Terminated
TerminatedNCT00755001
Clinical Study on BiHapro Total Hip System With Different Surface Coatings
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BiHapro hip stem with PPS Ti+Plasma HA | BiHapro hip stem with PPS Ti+Plasma HA |
| DEVICE | BiHapro hip stem with PPS Ti+BoneMaster HA | BiHapro hip stem with PPS Ti+BoneMaster HA |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2008-09-18
- Last updated
- 2017-07-07
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00755001. Inclusion in this directory is not an endorsement.