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

NCT05490186 | Terminated

• 1 other identifier: NYGH REB #21-0043
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Replacement, Total; Pain, Postoperative; Functional Independence

Outcome Measures

Primary Outcomes (1)

• Function

  Oxford knee score

  post-operatively 1 year

Secondary Outcomes (17)

• Quality of Life following knee surgery

  post-operatively at 2 years

• Quality of Life following knee surgery

  post-operatively at 6 weeks

• Quality of Life following knee surgery

  post-operatively at 6 months

• Quality of Life following knee surgery

  post-operatively at 1 year

• Pain intensity and effectiveness of analgesics

  Post-operatively at 6 weeks

Other Outcomes (1)

• Health Care Utilization

  Post-operatively at 6 weeks

Study Arms (3)

Manual Adjusted Mechanical Alignment

ACTIVE COMPARATOR

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

Robotic Assisted Adjusted Mechanical Alignment

EXPERIMENTAL

* 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

Robotic Assisted Kinematic Alignment: (Joint line restoration)

EXPERIMENTAL

\-- 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

Interventions

Total Knee Replacement PROCEDURE

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.

Also known as: Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration)

Manual Adjusted Mechanical Alignment; Robotic Assisted Adjusted Mechanical Alignment; Robotic Assisted Kinematic Alignment: (Joint line restoration)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North York General Hospital: lead

Study Sites (1)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Frank Mastrogiacomo, PhD

  North York General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Manager

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: August 5, 2022
• Study Start: November 16, 2021
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)