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Recruitment Status : Withdrawn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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Gap balanced surgical technique Procedure: Measured resection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- Patellofemoral tracking [ Time Frame: One year post-operatively ]Assessed using dynamic fluoroscopy.
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
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Brent Lanting, MD.||London Health Sciences Centre - University Hospital|