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

NCT ID: NCT01855906

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Gap balanced surgical technique

Intervention Type PROCEDURE

Gap balanced surgical technique

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.

Group Type ACTIVE_COMPARATOR

Measured resection

Intervention Type PROCEDURE

Measured resection surgical technique

Interventions

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Gap balanced surgical technique

Gap balanced surgical technique

Intervention Type PROCEDURE

Measured resection

Measured resection surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Brent Lanting

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brent Lanting, MD.

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre - University Hospital

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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103307

Identifier Type: -

Identifier Source: org_study_id

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