Clinical trial NCT01576445: Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Total Knee Arthroplasty
function
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: DePuy International
name: Royal Infirmary of Edinburgh
First posted: 2012-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in Functional knee range of motion from pre surgery to 6 months post surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: change in WOMAC from pre surgery to 6 month after surgery
timeFrame: 6 months after surgery
measure: Change in Timed up and Go test from pre-surgery to 6 month post surgery
timeFrame: 6 months after surgery
measure: Change in range of motion of the knee in prone from pre surgery to post surgery
timeFrame: 6 months after surgery
measure: Change in Objective daily physical activity from pre to 6 month post surgery
timeFrame: 6 month post surgery
measure: Change in knee extensor strength from pre surgery to 6 months after surgery
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: New Royal infirmary Edinburgh
Study officials:
References: