Clinical Trials Directory

Trials / Completed

CompletedNCT01576445

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Queen Margaret University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMid-vastus approachMid-vastus approach to avoid patellar eversion and to minimise the muscle split.
PROCEDUREmedial parapatellar approachmedial parapatellar approach

Timeline

Start date
2010-03-01
Primary completion
2012-01-01
Completion
2012-02-01
First posted
2012-04-12
Last updated
2012-04-12

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01576445. Inclusion in this directory is not an endorsement.