A prospective, randomized, controlled trial of Mechanical Axis with Soft Tissue Release Balancing vs Functional Alignment with Bony Release Balancing in Total Knee Replacement – A study using Stryker Mako Robotic-Arm Assisted Technology®.

Not Applicable

Active, not recruiting

• Conditions: Total Knee Arthroplasty; Musculoskeletal - Osteoarthritis; Surgery - Surgical techniques

• Registration Number: ACTRN12620000009910
• Lead Sponsor: Stryker Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

1. Patients are male or non-pregnant females requiring a primary total knee replacement for osteoarthritis and is indicated for robotic-assisted surgery
2. The patient has intact collateral ligaments
3. The patient is able to undergo CT scanning of the affected limb
4. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations

Exclusion Criteria

1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
2. Patient has had a previous osteotomy around the knee
3. The patient is morbidly obese (BMI greater than 40)
4. The patient has a deformity which will require the use of stems, wedges, or augments in conjunction with the Triathlon Total Knee System
5. The patient has a varus/valgus deformity equal to or greater than 15 degrees
6. The patient has a fixed flexion deformity equal to or greater than 15 degrees
7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration
9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restoration of normal feeling after surgery, assessed via the Forgotten Joint Score. For the purpose of this study a minimal clinically important difference of 14 points for the Forgotten Joint Score has been identified. [ Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months]