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

NCT04600583 | Active Not Recruiting FDA Device

• 1 other identifier: CAMELOT
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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

Keywords

Knee; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Joint feeling and Forgotten Joint Score

  To evaluate differences in joint feeling assessed via the Forgotten Joint Score. This newly-developed 12-item score ranges from 0 to 100 and assesses how aware recipients are of their joint in everyday life. Higher scores indicate a good outcome i.e. a high degree of forgetting the joint. For the purpose of this study a change in score of 14 points for the Forgotten Joint Score has been identified.

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months

Secondary Outcomes (17)

• Function and Oxford Knee Score

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months

• Function and The International Knee Society Score

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months

• Function and Knee Injury and Osteoarthritis Outcome Score

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months

• Pain and Oxford Knee Score

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months

• Pain and The International Knee Society Score

  Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months

Study Arms (2)

Alignment according to Functional Alignment philosophy

ACTIVE COMPARATOR

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.

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

Alignment to the patient's natural Mechanical axis

ACTIVE COMPARATOR

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.

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

Interventions

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) 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 according to Functional Alignment philosophy; Alignment to the patient's natural Mechanical axis

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stryker South Pacific: lead

Study Sites (1)

North Shore Hospital

Takapuna, Auckland, 0622, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 35858944 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Simon Young, Dr

  North Shore 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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 23, 2020
• Study Start: November 12, 2020
• Primary Completion: December 20, 2023
• Study Completion: March 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)