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

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 Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Knee Replacement, Total; Functional Independence
• Intervention / Treatment: Procedure: Total Knee Replacement

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mona Sawhney, PhD; Phone Number: 416-756-6000; Email: msawhney@nygh.on.ca
• Study Contact Backup: Name: Frank Mastrogiacomo, PhD; Email: frank.mastrogiacomo@nygh.on.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E1
      • Recruiting
      • North York General Hospital
      • Contact: Mona Sawhney, PhD; Phone Number: 4988 416-756-6000; Email: mona.sawhney@nygh.on.ca
      • Principal Investigator: Monakshi Sawhney, PhD
      • Principal Investigator: Frank Mastrogiacomo, PhD, MD, FRCPC
      • Sub-Investigator: Shawn Garbedian, MD, FRCPC
      • Sub-Investigator: Hossein Mehdian, MD, FRCSC
      • Sub-Investigator: Herman Dhotar, MD, FRCSC
      • Sub-Investigator: Kelvin Leung, MN, NP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Manual Adjusted Mechanical Alignment; Usual care: Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes; Distal femoral cut with 3-5 degrees of valgus from the anatomical axis (Based on the angle measurement on the 4 foot standing Xray). Correct for flexion contracture.; Measure the femoral size with the anterior referencing guides. Use 3 degrees external rotation to the Posterior condylar axis; Perform anterior, posterior and chamfer cuts with the 4 in 1 in appropriate external rotation; Extramedullary tibial alignment guide with 3-5 degrees posterior slope, and orthogonal cut to the tibial axis.; Resect posterior osteophytes; Place trial components and perform appropriate release/balance the gaps; Patellar replacement based on surgeon's discretion; Cementing the components with tourniquet inflation	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.; Other Names: Manual Adjusted Mechanical Alignment; Robotic Assisted Adjusted Mechanical Alignment; Robotic Assisted Kinematic Alignment: (Joint line restoration)
EXPERIMENTAL: Robotic Assisted Adjusted Mechanical Alignment; Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes; Place the femoral pins in the proximal incision and the tibial pins 4 finger breadths under the joint line; Map the knee and perform evaluation; Assess gaps, adjust the femoral axis to decrease soft tissue release (+/- 2 degrees), correct for flexion contracture; Verify and perform distal femoral cut, proximal tibial cut orthogonal (90 Degrees) to the tibial axis; Assess and balance extension gap with appropriate releases; Remap the posterior condylar axis, assess the flexion space, 3 degrees external rotation to the posterior condylar axis; Perform anterior, posterior and chamber cuts with the 4 in 1 (appropriate external rotation), followed by posterior osteophyte resection; Place trial components and balance the knee, soft tissue releases (1-2 mm); Patellar replacement based on surgeon's discretion; Cementing the components with tourniquet inflation	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.; Other Names: Manual Adjusted Mechanical Alignment; Robotic Assisted Adjusted Mechanical Alignment; Robotic Assisted Kinematic Alignment: (Joint line restoration)
EXPERIMENTAL: Robotic Assisted Kinematic Alignment: (Joint line restoration); -- Midline incision, no tourniquet, medial parapatellar arthrotomy, resect anterior osteophytes; Place femoral pins in proximal incision, tibial pins 4 finger breadths under joint line; Map and evaluate the knee, ROM, varus valgus testing at 0 & 90 degrees flexion; Distal femoral cut based on cartilage loss on medial and lateral femoral condyle (9mm total cut/condyle).; Perform distal femoral cut, maintain the joint line (femoral axis +/- 5 degrees); Perform proximal tibial cut within +/- 3 degrees, balance the gaps, differential between medial and lateral gaps = 1- 3mm.; Assess extension space, resect posterior osteophytes; Remap posterior condylar axis, place 4 in 1 at 0 degrees to the post condylar axis (aim = 9mm posterior condylar cuts); Resect posterior osteophytes, place trial components. Adjust cuts to achieve a balanced knee, maintain HKA axis +/- 3 degrees; Patellar replacement per surgeon discretion; Cement the components with tourniquet inflation	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.; Other Names: Manual Adjusted Mechanical Alignment; Robotic Assisted Adjusted Mechanical Alignment; Robotic Assisted Kinematic Alignment: (Joint line restoration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	Oxford knee score	post-operatively 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 2 years
Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 6 weeks
Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 6 months
Quality of Life following knee surgery	EuroQol 5D index	post-operatively at 1 year
Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 6 weeks
Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 6 months
Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 1 year
Pain intensity and effectiveness of analgesics	Brief Pain Inventory-Short Form - Pain Severity Index	Post-operatively at 2 years
Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 weeks
Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 6 months
Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 1 year
Satisfaction with knee surgery	Forgotten Joint Score	Post-operatively at 2 years
Function	Oxford knee score	post-operatively at 6 weeks
Function	Oxford knee score	post-operatively at 6 months
Function	Oxford knee score	pre-operatively
Function	Oxford knee score	post-operatively at 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Care Utilization	unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery	Post-operatively at 6 weeks

Collaborators and Investigators

• Sponsor: North York General Hospital
• Investigators: Principal Investigator: Frank Mastrogiacomo, PhD, North York General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2021
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): January 31, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (ACTUAL): August 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pain, Postoperative; Osteoarthritis
• Other Study ID Numbers: NYGH REB #21-0043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Knowledge translation will occur utilizing a variety of mechanisms. The results of this study will be disseminated at the Canadian Orthopaedic Association conference. They will also be published in an high impact journal. At the provincial level, the data from this study will be shared with Health Quality Ontario, as a requirement of the bundled care program. At the local level, the investigators will disseminate the results of this study as aggregate data at North York General Hospital with to the health care practitioners and administrators involved with caring for the arthroplasty patient population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes