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

Arthropathy of Knee Joint Clinical Trial

Official title:

3D Motion Analysis of Evolution Medial Pivot Knee VS Posterior Stabilized Knee Arthroplasty for Osteoarthritis of the Knee.Feasibility Pilot for a Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967161
• Other study ID #: OHREB 2009-240-01H
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: November 17, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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

1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.

2. Patients with any other joint replacement in the ipsilateral and contralateral limb.

3. Patients with evidence of active infection.

4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.

5. Patients with neuropathic joints.

6. Patients requiring structural bone grafts.

7. Patients with a documented allergy to cobalt chromium molybdenum.

8. Patient with a BMI larger than 30 kg/m2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.

2. Patients with any other joint replacement in the ipsilateral and contralateral limb.

3. Patients with evidence of active infection.

4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.

5. Patients with neuropathic joints.

6. Patients requiring structural bone grafts.

7. Patients with a documented allergy to cobalt chromium molybdenum.

8. Patient with a BMI larger than 30 kg/m2.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthropathy of Knee Joint
• Osteoarthritis

Intervention

Procedure:
• Total Knee Arthroplasty
Total Knee Arthroplasty
• Motion analysis
Motion analysis (Gait/EMG during walking and functional tasks)

Locations

Country	Name	City	State
Canada	The Ottawa General Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Wright Medical Technology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The motion analysis assessments of the knee		pre-op,6,12 months following surgery	No
Secondary	Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.		pre-op,6,12 and 24 months	No