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

This study has been completed.
Sponsor:
Collaborators:
DePuy International
Royal Infirmary of Edinburgh
Information provided by (Responsible Party):
Marietta van der Linden, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT01576445
First received: April 10, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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 Intervention Phase
Osteoarthritis
Procedure: Mid-vastus approach
Procedure: medial parapatellar approach
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • change in Functional knee range of motion from pre surgery to 6 months post surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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:
  • change in WOMAC from pre surgery to 6 month after surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in range of motion of the knee in prone from pre surgery to post surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month post surgery ] [ Designated as safety issue: No ]
    Objective daily physical activity is recorded using an activity monitor

  • Change in knee extensor strength from pre surgery to 6 months after surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Knee extensor strength is measured using a digital myometer


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576445

Locations
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

No publications provided

Responsible Party: Marietta van der Linden, Research Fellow Physiotherapy, Queen Margaret University
ClinicalTrials.gov Identifier: NCT01576445     History of Changes
Other Study ID Numbers: MIS1
Study First Received: April 10, 2012
Last Updated: April 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Margaret University:
Total Knee Arthroplasty
function

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014