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

NCT ID: NCT05490186

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2024-02-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Total Knee Replacement

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Total Knee Replacement

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North York General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mary Rahmat

Clinical Trials Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Mastrogiacomo, PhD

Role: PRINCIPAL_INVESTIGATOR

North York General Hospital

Locations

North York General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

NYGH REB #21-0043

Identifier Type: -

Identifier Source: org_study_id