Does restoring the native alignment of the knee improve soft tissue balance during total knee replacement surgery? A randomised controlled trial

Not Applicable

Active, not recruiting

• Conditions: Knee osteoarthritis; Rheumatoid arthritis; Musculoskeletal - Osteoarthritis; Inflammatory and Immune System - Rheumatoid arthritis; Surgery - Surgical techniques

• Registration Number: ACTRN12617001627347
• Lead Sponsor: Dr Samuel Macdessi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-13
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Patients who meet the indications for primary total knee replacement using the Smith & Nephew posterior-stabilized total knee arthroplasty system
Patients diagnosed with idiopathic osteoarthritis, rheumatoid arthritis or post-traumatic osteoarthritis

Exclusion Criteria

Revision knee replacement
Previous insufficiency fracture
Prior Grade 3 posterior cruciate ligament, posterolateral corner or lateral collateral ligament injury
Prior medial collateral ligament injury if it still a Grade 2 or Grade 3 laxity
Prior femoral, tibial or patellofemoral osteotomies
Other prior knee surgery (except arthroscopic meniscectomy or anterior cruciate ligament reconstruction)
Ipsilateral foot, ankle or hip arthritis
Preoperative range of motion <90 degrees and flexion contracture >20 degrees
Pregnant female, or planning on becoming pregnant during study follow-up period
Mental condition that may interfere with capacity to fulfil study requirements
Inability to provide fully informed consent due to cognitive incapacity or English language deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of soft-tissue balance using the VERASENSE™ (OrthoSensor, USA) pressure monitoring insert. The primary outcome is measurement of the initial intraoperative difference in pressure between the medial and lateral compartments at 10 degrees of flexion. [Intraoperative]

Secondary Outcome Measures

Name	Time	Method
Knee pain, symptoms and function using the Knee Osteoarthritis Outcome Score (KOOS)[Pre-op, 6 months, 1 year, 2 years];Patient's overall awareness of knee joint as measured by the Forgotten Joint Score (FJS-12)[Pre-op, 1 year, 2 years];Quality of life using the Euro Quality of Life (EQ5D-5L) score[Pre-op, 6 months, 2 years];ACORN (Arthroplasty Clinical Outcomes Registry) Satisfaction and Success score<br>[6 months, 2 years]