Clinical Study on BiHapro Total Hip System With Different... | NCT00755001

Studies
Clinical Study on BiHapro Total Hip System With Different Surface Coatings

NCT00755001

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Jul 7, 2017Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

BiHapro hip stem with PPS Ti+Plasma HA
BiHapro hip stem with PPS Ti+BoneMaster HA

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The site decided to stop the study

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 16, 2008

First Submission Date that Met QC Criteria

Sep 17, 2008

First Posted Date

Sep 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2017

Last Update Posted Date

Jul 7, 2017Actual

Name	Class
Biomet Spain Orthopaedics S.L.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BiHapro hip stem with PPS Ti+Plasma HA	Device	BiHapro hip stem with PPS Ti+Plasma HA	with Plasma HA

Measure	Description	Time Frame
Harris Hip Score		annual at least to 5 yr

Measure	Description	Time Frame
Radiographic Assessment		Annual; At least to 5 yr

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Total Hip Arthroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Aviles		Avilés			Spain
University Central Hospital of Asturias

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided