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Trial record 54 of 81025 for:    measured

The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation

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ClinicalTrials.gov Identifier: NCT01855906
Recruitment Status : Withdrawn
First Posted : May 17, 2013
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Brent Lanting, Lawson Health Research Institute

Brief Summary:
The purpose of this study is to examine the impact of two surgical techniques on the outcome of the knee replacement surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Gap balanced surgical technique Procedure: Measured resection Not Applicable

Detailed Description:

How stable a total knee replacement is depends on the correct and precise rotation of the femoral component. Abnormal femoral component rotation has been associated with numerous adverse conditions including knee instability, knee pain, scar tissue, and abnormal knee motion. Controversy exists, however, regarding the most favorable surgical technique to determine accurate femoral component rotation. Some doctors prefer a measured resection technique in which landmarks on the femur bone are used to determine where to place the femoral component. Others recommend a gap-balancing technique in which the femoral component is positioned by balancing the ligaments of the knee and placing it in the position where each ligament is equally strained.

The purpose of this study is to examine the impact of the measured resection and gap-balancing surgical technique on how the total knee replacement moves and patient knee outcome scores. Knee outcome scores are assessed from the responses given by patients to questions about outcomes associated with total knee replacement related to pain, symptoms, activities of daily living, sport and recreational function, and knee-related quality of life.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Gap balanced surgical technique
Study patients in this arm of the study will have their knee replacement done using the gap balanced technique. Gap balancing adjusts the bony cuts for femoral rotation to balance the soft tissues of the knee in flexion.
Procedure: Gap balanced surgical technique
Gap balanced surgical technique

Active Comparator: Measured resection surgical technique
Study patients in this arm of the study will have their knee replacement done using the measured resection surgical technique. Pre-determined bony cuts are made and appropriate balance is obtained by judicious soft tissue releases as required.
Procedure: Measured resection
Measured resection surgical technique




Primary Outcome Measures :
  1. The primary objective will be to assess coronal balance through a range of motion. [ Time Frame: One year post-operatively ]
    Assessed through dynamic fluoroscopic analysis.


Secondary Outcome Measures :
  1. Patellofemoral tracking [ Time Frame: One year post-operatively ]
    Assessed using dynamic fluoroscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgeon and patient have determined that patient requires a primary total knee arthroplasty and agrees to participate and signs the informed consent for study.

Exclusion Criteria:

  • History of alcoholism
  • Unable to speak English
  • Inflammatory Arthritis
  • Pregnant women or any woman with plans to begin a family.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855906


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Brent Lanting, MD. London Health Sciences Centre - University Hospital

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Responsible Party: Brent Lanting, Orthopaedic Surgeon, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01855906     History of Changes
Other Study ID Numbers: 103307
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Keywords provided by Brent Lanting, Lawson Health Research Institute:
Total knee replacement
Gap balanced
Measured resection
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases