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

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

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'.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Mid-vastus approach; Procedure: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • New Royal infirmary Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Functional knee range of motion from pre surgery to 6 months post surgery	The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in WOMAC from pre surgery to 6 month after surgery	Western Ontario McMaster Universities (WOMAC) osteoarthris Index is patient-reported outcome and has three components: Pain, Stiffness and Function.	6 months after surgery
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	The range of motion of the knee is measured using a manual goniometer.	6 months after surgery
Change in Objective daily physical activity from pre to 6 month post surgery	Objective daily physical activity is recorded using an activity monitor	6 month post surgery
Change in knee extensor strength from pre surgery to 6 months after surgery	Knee extensor strength is measured using a digital myometer	6 months after surgery

Collaborators and Investigators

• Sponsor: Queen Margaret University
• Collaborators: DePuy International; Royal Infirmary of Edinburgh

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: function; Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: MIS1