Clinical trial NCT05490186: Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
Official title: Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Replacement, Total
Pain, Postoperative
Functional Independence
Lead sponsor: North York General Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.


Eligibility criteria: Inclusion Criteria:

* undergoing unilateral TKR for the treatment of osteoarthritis
* between the age of 18 and 85 years of age
* able to read, speak and understand English, have a telephone
* are able to provide consent

Exclusion Criteria:

* enrolled in another study, are
* undergoing revision surgery or bilateral surgery, and are
* over the age of 85 years. Patients will also be excluded if they
* have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked

Primary outcomes:
measure: Function
timeFrame: post-operatively 1 year
Secondary outcomes:
measure: Quality of Life following knee surgery
timeFrame: post-operatively at 2 years
measure: Quality of Life following knee surgery
timeFrame: post-operatively at 6 weeks
measure: Quality of Life following knee surgery
timeFrame: post-operatively at 6 months
measure: Quality of Life following knee surgery
timeFrame: post-operatively at 1 year
measure: Pain intensity and effectiveness of analgesics
timeFrame: Post-operatively at 6 weeks
measure: Pain intensity and effectiveness of analgesics
timeFrame: Post-operatively at 6 months
measure: Pain intensity and effectiveness of analgesics
timeFrame: Post-operatively at 1 year
measure: Pain intensity and effectiveness of analgesics
timeFrame: Post-operatively at 2 years
measure: Satisfaction with knee surgery
timeFrame: Post-operatively at 6 weeks, 6 months, 1 year and 2 years
measure: Satisfaction with knee surgery
timeFrame: Post-operatively at 6 weeks
measure: Satisfaction with knee surgery
timeFrame: Post-operatively at 6 months
measure: Satisfaction with knee surgery
timeFrame: Post-operatively at 1 year
measure: Satisfaction with knee surgery
timeFrame: Post-operatively at 2 years
measure: Function
timeFrame: post-operatively at 6 weeks
measure: Function
timeFrame: post-operatively at 6 months
measure: Function
timeFrame: pre-operatively
measure: Function
timeFrame: post-operatively at 2 years
Other outcomes:
measure: Health Care Utilization
timeFrame: Post-operatively at 6 weeks
Locations:
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
Study officials:
affiliation: North York General Hospital
name: Frank Mastrogiacomo, PhD
role: PRINCIPAL_INVESTIGATOR
References: