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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01855906
• Other study ID #: 103307
• Status: Withdrawn
• Phase: N/A
• First received: May 14, 2013
• Last updated: March 9, 2016
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Gap balanced surgical technique
Gap balanced surgical technique
• Measured resection
Measured resection surgical technique

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective will be to assess coronal balance through a range of motion.	Assessed through dynamic fluoroscopic analysis.	One year post-operatively	No
Secondary	Patellofemoral tracking	Assessed using dynamic fluoroscopy.	One year post-operatively	No