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

Not Applicable

Completed

• Conditions: Arthropathy of Knee Joint

• Registration Number: NCT00967161
• Lead Sponsor: Ottawa Hospital Research Institute

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

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 Timeline

• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2012-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The motion analysis assessments of the knee	pre-op,6,12 months following surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada