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

NCT01576445 | Completed Phase 2

• 1 other identifier: MIS1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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'.

Conditions

Osteoarthritis

Keywords

Total Knee Arthroplasty; function

Outcome Measures

Primary Outcomes (1)

• change in Functional knee range of motion from pre surgery to 6 months post surgery

  The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis

  6 months after surgery

Secondary Outcomes (5)

• change in WOMAC from pre surgery to 6 month after surgery

  6 months after surgery

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

  6 months after surgery

• Change in range of motion of the knee in prone from pre surgery to post surgery

  6 months after surgery

• Change in Objective daily physical activity from pre to 6 month post surgery

  6 month post surgery

• Change in knee extensor strength from pre surgery to 6 months after surgery

  6 months after surgery

Study Arms (2)

Mid-vastus approach

EXPERIMENTAL

Procedure: Mid-vastus approach

medial parapatellar approach

EXPERIMENTAL

Procedure: medial parapatellar approach

Interventions

Mid-vastus approach PROCEDURE

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

Mid-vastus approach

medial parapatellar approach PROCEDURE

medial parapatellar approach

medial parapatellar approach

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total knee arthroplasty
• Osteoarthritis
• Surgery at Royal Infirmary Edinburgh by participating surgeons

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Margaret University: lead
• DePuy International: collaborator
• Royal Infirmary of Edinburgh: collaborator

Study Sites (1)

New Royal infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow Physiotherapy

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

GB (1)