Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing... | NCT00376610

Studies
Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

NCT00376610

Sponsor

Frederiksberg University Hospital

Status

Completed

Last Update Posted

Jul 4, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Bearings

Interventions

ASR/Re-cap

Countries

Denmark

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 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

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

Sep 14, 2006

First Submission Date that Met QC Criteria

Sep 14, 2006

First Posted Date

Sep 15, 2006Estimated

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 3, 2007

Last Update Posted Date

Jul 4, 2007Estimated

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ASR/Re-cap	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of THA
ASA I-II
Willing to return for follow-up evaluations

Exclusion Criteria:

Collum femurs < 2 cm
Cysts > 1 cm
Caput necrose

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne Borgwardt	Frederiksberg Univesity Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frederiksberg University Hospital		Frederiksberg	Copenhagen	2000	Denmark