Outcome Analysis of the Oxford Partial Knee Arthroplasty | NCT00759616

Studies
Outcome Analysis of the Oxford Partial Knee Arthroplasty

NCT00759616

Sponsor

Zimmer Biomet

Status

Completed

Last Update Posted

Jun 16, 2017Actual

Enrollment

156Actual

Phase

Not Applicable

Conditions

Knee Arthroplasty

Interventions

Oxford Partial Knee

Countries

Canada

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

Jun 2017

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

Apr 2003

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 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

Jun 15, 2017

Last Update Posted Date

Jun 16, 2017Actual

Name	Class
Dartmouth General Hospital	OTHER

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

Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty

Detailed Description

Utilization of systematic outcome measurements and specific designated time frames to monitor patient satisfactions will assist in analysing this type of prosthesis and the post operative period. Data collected will be added to the compiled information from previous studies in relation to the Oxford knee.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: Oxford Partial Knee

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxford Partial Knee	Device	Oxford Partial Knee	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC, SF12, oxford Knee,KSCRS		3weeks, 3months,6months, yearly

Secondary Outcomes

Measure	Description	Time Frame
Length of Hospital Stay		Postop

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient Suitable for Knee Replacement

Exclusion Criteria:

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth General Hospital		Dartmouth			Canada