A Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement Using Stryker's Mako Robot

NCT ID: NCT04600583

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2025-03-31

Brief Summary

This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.

Conditions

Osteoarthritis

Study Design

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

Study Groups

Alignment according to Functional Alignment philosophy

Patients randomized to this group will undergo a TKA (total knee arthroplasty) to receive a Triathlon Total Knee System aligned according to Functional Alignment philosophy. This method of implant alignment is defined by a patient's native joint line as well as the soft tissue envelope. Triathlon Total Knee System components will be positioned relative to intra-operative soft tissue laxity assessment. A mobile application (KneeBalancer) will be used to assist surgeon decision making during the dynamic joint balancing surgical step.

Group Type: ACTIVE_COMPARATOR

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)

Intervention Type: DEVICE

All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.

Alignment to the patient's natural Mechanical axis

Patients randomized to this group will undergo a TKA (total knee arthroplasty) to receive a Triathlon Total Knee System neutrally aligned to the Mechanical axis. More specifically, the femoral component and tibial component are aligned 0° to the mechanical axis of each respective limb. Femoral component rotation is fixed to the trans-epicondylar axis. Soft tissue releases are performed at the discretion of the surgeon to achieve balance and full range of motion.

Group Type: ACTIVE_COMPARATOR

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)

Intervention Type: DEVICE

All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.

Interventions

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)

All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient is a male or non-pregnant female between the ages of 40-80 years.
• The patient requires a primary total knee replacement and is indicated for robotic-assisted surgery.
• Patient is deemed appropriate for a cruciate retaining knee replacement.
• The patient has a primary diagnosis of osteoarthritis (OA).
• The patient has intact collateral ligaments.
• The patient is able to undergo CT scanning of the affected limb.
• The patient has signed the study specific, ethics-approved, Informed Consent document.
• The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria

• The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
• Patient has had a previous osteotomy around the knee.
• The patient is morbidly obese (BMI ≥ 40).
• The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
• The patient has a varus/valgus deformity ≥ 15°.
• The patient has a fixed flexion deformity ≥ 15°.
• The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
• The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
• Patient has a cognitive impairment, an intellectual disability or a mental illness.
• The patient is pregnant.
• The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker South Pacific

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Young, Dr

Role: PRINCIPAL_INVESTIGATOR

North Shore Hospital

Locations

North Shore Hospital

Takapuna, Auckland, New Zealand

Countries

New Zealand

References

Young SW, Zeng N, Tay ML, Fulker D, Esposito C, Carter M, Bayan A, Farrington B, Van Rooyen R, Walker M. A prospective randomised controlled trial of mechanical axis with soft tissue release balancing vs functional alignment with bony resection balancing in total knee replacement-a study using Stryker Mako robotic arm-assisted technology. Trials. 2022 Jul 20;23(1):580. doi: 10.1186/s13063-022-06494-4.

Reference Type: DERIVED

PMID: 35858944 (View on PubMed)

Other Identifiers

CAMELOT

Identifier Type: -

Identifier Source: org_study_id