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NCT00755001 Clinical Trial

Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Osteoarthritis Clinical Trial

Official title:
Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00755001
Other study ID # BMET EP 01
Secondary ID
Status Terminated
Phase N/A
First received September 16, 2008
Last updated July 6, 2017
Start date May 2007
Est. completion date May 2011

Study information
Verified date July 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group N/A to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain University Hospital of Aviles Aviles
Spain University Central Hospital of Asturias Oviedo

Sponsors (2)
Lead Sponsor Collaborator
Zimmer Biomet Biomet Spain Orthopaedics S.L.

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Harris Hip Score annual at least to 5 yr
Secondary Radiographic Assessment Annual; At least to 5 yr
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