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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
Information provided by (Responsible Party):

Study Description
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'.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Mid-vastus approach Procedure: medial parapatellar approach Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Primary Completion Date : January 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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

United Kingdom
New Royal infirmary Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
Queen Margaret University
DePuy International
Royal Infirmary of Edinburgh
More Information

Responsible Party: Marietta van der Linden, Research Fellow Physiotherapy, Queen Margaret University
ClinicalTrials.gov Identifier: NCT01576445     History of Changes
Other Study ID Numbers: MIS1
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012

Keywords provided by Marietta van der Linden, Queen Margaret University:
Total Knee Arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases