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

North York General Hospital261 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

261

Conditions

Knee Replacement, Total Pain, Postoperative Functional Independence

Interventions

Total Knee ReplacementPROCEDURE

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.

Outcomes

Primary Outcomes

Function

Oxford knee score

Time frame: post-operatively 1 year

Secondary Outcomes

Quality of Life following knee surgery

EuroQol 5D index

Time frame: post-operatively at 2 years

Quality of Life following knee surgery

EuroQol 5D index

Time frame: post-operatively at 6 weeks

Quality of Life following knee surgery

EuroQol 5D index

Time frame: post-operatively at 6 months

Quality of Life following knee surgery

EuroQol 5D index

Time frame: post-operatively at 1 year

Pain intensity and effectiveness of analgesics

Brief Pain Inventory-Short Form - Pain Severity Index

Time frame: Post-operatively at 6 weeks

Pain intensity and effectiveness of analgesics

Brief Pain Inventory-Short Form - Pain Severity Index

Time frame: Post-operatively at 6 months

Pain intensity and effectiveness of analgesics

Brief Pain Inventory-Short Form - Pain Severity Index

Time frame: Post-operatively at 1 year

Pain intensity and effectiveness of analgesics

Brief Pain Inventory-Short Form - Pain Severity Index

Time frame: Post-operatively at 2 years