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®.

Stryker South Pacific1 site in 1 country278 target enrollmentNovember 12, 2020

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Stryker South Pacific
Enrollment: 278
Locations: 1
Primary Endpoint: Joint feeling and Forgotten Joint Score
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.

Registry

clinicaltrials.gov

Start Date

November 12, 2020

End Date

March 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stryker South Pacific

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient is a male or non-pregnant female between the ages of 40-80 years.
•The patient requires a primary total knee replacement and is indicated for robotic-assisted surgery.
•Patient is deemed appropriate for a cruciate retaining knee replacement.
•The patient has a primary diagnosis of osteoarthritis (OA).
•The patient has intact collateral ligaments.
•The patient is able to undergo CT scanning of the affected limb.
•The patient has signed the study specific, ethics-approved, Informed Consent document.
•The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria

•The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
•Patient has had a previous osteotomy around the knee.
•The patient is morbidly obese (BMI ≥ 40).
•The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
•The patient has a varus/valgus deformity ≥ 15°.
•The patient has a fixed flexion deformity ≥ 15°.
•The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
•The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
•Patient has a cognitive impairment, an intellectual disability or a mental illness.

Outcomes

Primary Outcomes

Joint feeling and Forgotten Joint Score

Time Frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months

To evaluate differences in joint feeling assessed via the Forgotten Joint Score. This newly-developed 12-item score ranges from 0 to 100 and assesses how aware recipients are of their joint in everyday life. Higher scores indicate a good outcome i.e. a high degree of forgetting the joint. For the purpose of this study a change in score of 14 points for the Forgotten Joint Score has been identified.

Secondary Outcomes

Function and The International Knee Society Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months)
Early pain(In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months)
Function and Oxford Knee Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Pain and Knee Injury and Osteoarthritis Outcome Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Pain and Oxford Knee Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Pain and The International Knee Society Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months)
Pain and Visual Analogue Scale(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Function and Knee Injury and Osteoarthritis Outcome Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Health related quality of life and Euro-Qol (EQ-5D-3L)(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Early function(In-patient setting (< 5 days post-operation))
Blood loss(Intra-operative)
Adjustments to balance(Intra-operative)
Satisfaction and Net Promoter Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
Ability to reach target knee balance as assessed by alignment angles and gaps(Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months)