Oxford Partial Knee Kinematics Gait Analysis Study | NCT01454908

Studies
Oxford Partial Knee Kinematics Gait Analysis Study

NCT01454908

Sponsor

The CORE Institute

Status

Unknown status

Last Update Posted

Oct 19, 2011Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Medial Knee Compartment Arthritis

Interventions

Oxford Partial Knee

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

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

Apr 2006

Primary Completion Date

Aug 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 13, 2011

First Submission Date that Met QC Criteria

Oct 18, 2011

First Posted Date

Oct 19, 2011Estimated

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

Oct 18, 2011

Last Update Posted Date

Oct 19, 2011Estimated

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

The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.

Detailed Description

Not provided

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Partial Knee Arthroplasty	Other	Oxford Mobile Bearing Unicompartmental Knee Arthroplasties	Device: Oxford Partial Knee

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxford Partial Knee	Device	The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.	Partial Knee Arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Society Score (KSS)		up to 1 month pre-operatively and at 1 year post operatively

Secondary Outcomes

Measure	Description	Time Frame
Range of Motion (ROM)		up to 1 month pre-operatively and at 1 year post operatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with medial knee compartment arthritis

Exclusion Criteria:

Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
Patients with significant diseases of other joints of the lower extremity
Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).

Accepts Healthy Volunteers

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SHRI-CORE Orthopedic Research Lab		Sun City West	Arizona	85375	United States

Type	Date	Date Unknown
Release	Feb 10, 2014
Reset	Mar 21, 2014

Submission Tracking

Estimated Results First Submitted Date

Feb 10, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 10, 2014			Mar 21, 2014