Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

Pain, Postoperative Clinical Trial

Official title:

Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490186
• Other study ID #: NYGH REB #21-0043
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2022
• Source: North York General Hospital
• Contact: Mona Sawhney, PhD
• Phone: 416-756-6000
• Email: msawhney[@]nygh.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Independence
• Knee Replacement, Total
• Osteoarthritis
• Pain, Postoperative

Intervention

Procedure:
• Total Knee Replacement
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.

Locations

Country	Name	City	State
Canada	North York General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
North York General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Care Utilization	unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery	Post-operatively at 6 weeks
Primary	Function	Oxford knee score	post-operatively 1 year
Secondary	Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 2 years
Secondary	Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 6 weeks
Secondary	Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 6 months
Secondary	Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 1 year
Secondary	Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 6 weeks
Secondary	Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 6 months
Secondary	Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 1 year
Secondary	Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 2 years
Secondary	Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Secondary	Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 weeks
Secondary	Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 months
Secondary	Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 1 year
Secondary	Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 2 years
Secondary	Function	Oxford knee score	post-operatively at 6 weeks
Secondary	Function	Oxford knee score	post-operatively at 6 months
Secondary	Function	Oxford knee score	pre-operatively
Secondary	Function	Oxford knee score	post-operatively at 2 years