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

NCT ID: NCT01576445

Last Updated: 2012-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-02-29

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'.

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

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mid-vastus approach

Group Type: EXPERIMENTAL

Mid-vastus approach

Intervention Type: PROCEDURE

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

medial parapatellar approach

Group Type: EXPERIMENTAL

medial parapatellar approach

Intervention Type: PROCEDURE

medial parapatellar approach

Interventions

Mid-vastus approach

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

Intervention Type: PROCEDURE

medial parapatellar approach

medial parapatellar approach

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: collaborator

Royal Infirmary of Edinburgh

OTHER

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Marietta van der Linden

Research Fellow Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New Royal infirmary Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

MIS1

Identifier Type: -

Identifier Source: org_study_id