Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01576445|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Mid-vastus approach Procedure: medial parapatellar approach||Phase 2|
This study is a prospective randomized controlled double blind trial in which both immediate post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee replacement surgery will be assessed for two different types of surgical approach; Medial Parapatellar and Mid-vastus.
Functional outcome will be assessed by recording the kinematics of the lower limb joints in addition to muscle activity (electromyography) during walking, stair ascending and descending and getting up from a chair through computerized 3D motion analysis. Outcome measures will be recorded immediate post surgery and at medium follow-up and will cover all areas of the World Health Organisation, International Components of Functioning, Disability and Health (ICF) components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and 'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps, patients operated using the Mid-vastus approach will have better muscle function and will therefore have more normal knee range of motion, knee joint loading and muscle activity patterns compared to those with the Medial Parapatellar approach.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomised Controlled Trial to Compare the Speed of Recovery and Functional Outcome Following Total Knee Replacement (TKR) Using a Quadriceps Sparing Approach to the Knee Against a Standard Medial Parapatellar Surgical Exposure|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||February 2012|
|Experimental: Mid-vastus approach||
Procedure: Mid-vastus approach
Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.
|Experimental: medial parapatellar approach||
Procedure: medial parapatellar approach
medial parapatellar approach
- change in Functional knee range of motion from pre surgery to 6 months post surgery [ Time Frame: 6 months after surgery ]The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis
- change in WOMAC from pre surgery to 6 month after surgery [ Time Frame: 6 months after surgery ]Western Ontario McMaster Universities (WOMAC) osteoarthris Index is patient-reported outcome and has three components: Pain, Stiffness and Function.
- Change in Timed up and Go test from pre-surgery to 6 month post surgery [ Time Frame: 6 months after surgery ]
- Change in range of motion of the knee in prone from pre surgery to post surgery [ Time Frame: 6 months after surgery ]The range of motion of the knee is measured using a manual goniometer.
- Change in Objective daily physical activity from pre to 6 month post surgery [ Time Frame: 6 month post surgery ]Objective daily physical activity is recorded using an activity monitor
- Change in knee extensor strength from pre surgery to 6 months after surgery [ Time Frame: 6 months after surgery ]Knee extensor strength is measured using a digital myometer
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): NCT01576445
|New Royal infirmary Edinburgh|
|Edinburgh, United Kingdom, EH16 4SA|