Clinical Study on BiHapro Total Hip System With Different Surface Coatings
July 6, 2017 updated by: Zimmer Biomet
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aviles, Spain
- University Hospital of Aviles
-
Oviedo, Spain
- University Central Hospital of Asturias
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Total Hip Arthroplasty
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
with Plasma HA
BiHapro Hip stem with PPS Ti + Plasma HA
|
BiHapro hip stem with PPS Ti+Plasma HA
Other Names:
|
|
with BoneMaster HA
BiHapro Hip stem with PPS Ti + BoneMaster HA
|
BiHapro hip stem with PPS Ti+BoneMaster HA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Harris Hip Score
Time Frame: annual at least to 5 yr
|
annual at least to 5 yr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Radiographic Assessment
Time Frame: Annual; At least to 5 yr
|
Annual; At least to 5 yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 16, 2008
First Submitted That Met QC Criteria
September 17, 2008
First Posted (Estimate)
September 18, 2008
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMET EP 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.