Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT00967161
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2009-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: