Does Soft Tissue Balancing Using Intra-Operative Pressure Sensors Improve Clinical Outcomes in Total Knee Arthroplasty? A Multi-Centre Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Osteoarthritis; Rheumatoid arthritis; Musculoskeletal - Osteoarthritis; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Surgical techniques

• Registration Number: ACTRN12618000817246
• Lead Sponsor: Dr Samuel Macdessi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-11
• Study Completion: 2021-05-20
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. All patients suitable for TKA aged 20-85 years
2. Patients who meet the indications for a primary unilateral or bilateral total knee arthroplasty using the Smith & Nephew Legion or Genesis II cruciate-retaining or posterior-stabilised total knee arthroplasty system
3. Subjects diagnosed with one or more of the following conditions: osteoarthritis; rheumatoid or other inflammatory arthritis; post-traumatic osteoarthritis

Exclusion Criteria

1. Any surgery where increased prosthetic constraint will be required due to significant ligament deficiencies (such as constrained condylar or rotating hinge prostheses)
2. Any surgery performed for acute fracture or tumour involvement
3. Participants unable to provide consent or complete questionnaires due to cognitive incapacity or English language deficit
4. Participants unable to commit to full follow-up schedule over two years (due to geographic distance or physical challenges)
5. Pregnant female, or planning on becoming pregnant during study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the average score of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that are most specific to recovery after total knee arthroplasty: pain, symptoms, function in daily living and knee-related quality of life.[1 year-2 weeks pre-operatively and 1-year post-operatively ]