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Clinical Trials/NCT00967161
NCT00967161
Completed
N/A

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.

Ottawa Hospital Research Institute1 site in 1 country50 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arthropathy of Knee Joint
Sponsor
Ottawa Hospital Research Institute
Enrollment
50
Locations
1
Primary Endpoint
The motion analysis assessments of the knee
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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.

Outcomes

Primary Outcomes

The motion analysis assessments of the knee

Time Frame: pre-op,6,12 months following surgery

Secondary Outcomes

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

Study Sites (1)

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