Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Mid-vastus approach; Procedure: medial parapatellar approach

• Registration Number: NCT01576445
• Lead Sponsor: Queen Margaret University

Brief Summary

When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. This means that we put people randomly into two groups, one group will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the 'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus approach recover quicker and have a better short-term functional outcome than people who receive the 'Medial parapatellar approach'.

Detailed Description

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 Timeline

• Study Start: 2010-03
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Status Verified: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Last Update Submitted: 2012-04-10
• Study First Posted: 2012-04-12
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Total knee arthroplasty
• Osteoarthritis
• Surgery at Royal Infirmary Edinburgh by participating surgeons

Exclusion Criteria

• A Body Mass Index of more than 40
• Fixed valgus deformity of more than 15 degrees
• Inflammatory polyarthritis
• disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain
• dementia
• severe visual impairment
• neurological conditions affecting movement
• inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid-vastus approach	Mid-vastus approach	-
medial parapatellar approach	medial parapatellar approach	-

Primary Outcome Measures

Name	Time	Method
change in Functional knee range of motion from pre surgery to 6 months post surgery	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

Secondary Outcome Measures

Name	Time	Method
change in WOMAC from pre surgery to 6 month after surgery	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	6 months after surgery
Change in range of motion of the knee in prone from pre surgery to post surgery	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	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	6 months after surgery	Knee extensor strength is measured using a digital myometer

Trial Locations

Locations (1)

New Royal infirmary Edinburgh; 🇬🇧 Edinburgh, United Kingdom