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Completed

NCT Number: NCT00967161

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

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).

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Key information

Conditions

Arthropathy of Knee Joint

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa General Hospital

Ottawa, Ontario, k1Y 4E9, Canada

About this study

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

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty

Procedure

Total Knee Arthroplasty

Other names: non applicable

Motion analysis

Procedure

Motion analysis (Gait/EMG during walking and functional tasks)

Other names: non applicable

Primary outcomes

  1. The motion analysis assessments of the knee

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

Secondary outcomes

  1. Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.

    Time frame: pre-op,6,12 and 24 months

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Stryker Trauma and Extremities

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2009
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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