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Completed

NCT Number: NCT01576445

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

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'.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Royal infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mid-vastus approach

Procedure

Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.

Medial Parapatellar approach

Procedure

medial parapatellar approach

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Change in Timed up and Go test from pre-surgery to 6 month post surgery

    Time frame: 6 months after surgery

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Collaborators

  • DePuy International
  • Royal Infirmary of Edinburgh

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2012
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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