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

NCT00967161 | Completed

• 1 other identifier: OHREB 2009-240-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Arthropathy of Knee Joint

Keywords

knee replacement motion analysis

Outcome Measures

Primary Outcomes (1)

• The motion analysis assessments of the knee

  pre-op,6,12 months following surgery

Secondary Outcomes (1)

• Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.

  pre-op,6,12 and 24 months

Study Arms (2)

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

Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty

Also known as: non applicable

Evolution Medial Pivot Knee; Triathlon PS Knee

Motion analysis PROCEDURE

Motion analysis (Gait/EMG during walking and functional tasks)

Also known as: non applicable

Evolution Medial Pivot Knee; Triathlon PS Knee

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

The Ottawa General Hospital

Ottawa, Ontario, k1Y 4E9, Canada

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Geoffrey Dervin, MD,MSc,FRCSC

  OHRI / The Ottawa Hospital/ University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CA (1)