Motion Analysis of EMP Knee Versus Posterior Stabilized K... | NCT00967161

Studies
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis

NCT00967161

Sponsor

Ottawa Hospital Research Institute

Status

Completed

Last Update Posted

Nov 18, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Arthropathy of Knee Joint

Interventions

Total Knee Arthroplasty
Motion analysis

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

Nov 2015

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

Jan 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Aug 26, 2009

First Submission Date that Met QC Criteria

Aug 26, 2009

First Posted Date

Aug 27, 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

Nov 17, 2015

Last Update Posted Date

Nov 18, 2015Estimated

Name	Class
Stryker Trauma and Extremities	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

The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).

Detailed Description

Inclusion:

40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.

Patients who do not meet any exclusion criteria.

Exclusion:

Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
Patients with any other joint replacement in the ipsilateral and contralateral limb.
Patients with evidence of active infection.
Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
Patients with neuropathic joints.
Patients requiring structural bone grafts.
Patients with a documented allergy to cobalt chromium molybdenum.
Patient with a BMI larger than 30 kg/m2.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evolution Medial Pivot Knee	Experimental	20 Patients will receive the EMP Knee Implant	Procedure: Total Knee Arthroplasty Procedure: Motion analysis
Triathlon PS Knee	Active Comparator	20 Patients will receive the Triathlon PS Knee	Procedure: Total Knee Arthroplasty Procedure: Motion analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Knee Arthroplasty	Procedure	Total Knee Arthroplasty	Evolution Medial Pivot Knee Triathlon PS Knee

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The motion analysis assessments of the knee		pre-op,6,12 months following surgery

Secondary Outcomes

Measure	Description	Time Frame
Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.		pre-op,6,12 and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria.

Exclusion Criteria:

Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
Patients with any other joint replacement in the ipsilateral and contralateral limb.
Patients with evidence of active infection.
Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
Patients with neuropathic joints.
Patients requiring structural bone grafts.
Patients with a documented allergy to cobalt chromium molybdenum.
Patient with a BMI larger than 30 kg/m2.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geoffrey Dervin, MD,MSc,FRCSC	OHRI / The Ottawa Hospital/ University of Ottawa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ottawa General Hospital		Ottawa	Ontario	k1Y 4E9	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided