Clinical trial NCT00967161: Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy of Knee Joint
Keywords: knee replacement motion analysis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
First posted: 2009-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

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.

Primary outcomes:
measure: The motion analysis assessments of the knee
timeFrame: pre-op,6,12 months following surgery
Secondary outcomes:
measure: Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.
timeFrame: pre-op,6,12 and 24 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa General Hospital
state: Ontario
Study officials:
affiliation: OHRI / The Ottawa Hospital/ University of Ottawa
name: Geoffrey Dervin, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: