Medium and Long Term Outcome of Total Hip Arthroplasty Us... | NCT00951145

Studies
Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem

NCT00951145

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Apr 9, 2013Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Osteoarthritis of the Hip

Interventions

Not provided

Countries

United States

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 31, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 2009Estimated

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

Apr 8, 2013

Last Update Posted Date

Apr 9, 2013Estimated

Name	Class
Stryker Orthopaedics	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 is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of patients. All patients eligible for inclusion will be identified. The investigators hypothesize that the outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stems.

Detailed Description

Not provided

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

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stem

Secondary Outcomes

Measure	Description	Time Frame
Proximally coated tapered stems can be used for patients with various bone types, bone morphology, and underlying diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem.
Patients with hip fracture undergoing THA will also be included.
Patients willing and able to comply with follow-up requirements and self-evaluations.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Parvizi Javad, MD	Rothman Institute	Principal Investigator
Hozack William, MD	Rothman Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute		Philadelphia	Pennsylvania	19107	United States

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided