NCT00755001

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

September 16, 2008

Last Update Submit

July 6, 2017

Conditions

Osteoarthritis

Keywords

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score

    annual at least to 5 yr

Secondary Outcomes (1)

  • Radiographic Assessment

    Annual; At least to 5 yr

Study Arms (2)

with Plasma HA

BiHapro Hip stem with PPS Ti + Plasma HA

Device: BiHapro hip stem with PPS Ti+Plasma HA

with BoneMaster HA

BiHapro Hip stem with PPS Ti + BoneMaster HA

Device: BiHapro hip stem with PPS Ti+BoneMaster HA

Interventions

BiHapro hip stem with PPS Ti+Plasma HADEVICE

BiHapro hip stem with PPS Ti+Plasma HA

Also known as: BiHapro hip stem
with Plasma HA
BiHapro hip stem with PPS Ti+BoneMaster HADEVICE

BiHapro hip stem with PPS Ti+BoneMaster HA

Also known as: BiHapro hip stem
with BoneMaster HA

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Total Hip Arthroplasty

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Aviles

Avilés, Spain

Location

University Central Hospital of Asturias

Oviedo, Spain

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

May 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

ES(2)