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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

Primary Purpose

Osteoarthritis

Status

Not yet recruiting

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee, Arthroplasty

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Alignment according to Functional Alignment philosophy

Alignment to the patient's natural Mechanical axis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Function and Oxford Knee Score

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Oxford Knee Score. This score ranges from 0 to 48 where a higher score indicates a better outcome.

Function and The International Knee Society Score

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome.

Function and Knee Injury and Osteoarthritis Outcome Score

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms.

Pain and Oxford Knee Score

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Oxford Knee Score. This score ranges from 0 to 48 where a higher score indicates a better outcome.

Pain and The International Knee Society Score

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome.

Pain and Knee Injury and Osteoarthritis Outcome Score

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms.

Pain and Visual Analogue Scale

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following graphic measurement instrument: Visual Analogue Scale. This scale is a continuum between no pain and the worst possible pain imaginable.

Satisfaction and Net Promoter Score

To evaluate differences in satisfaction between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Net Promoter. This score ranges from -100 to 100 where the upper end indicates the patient's recommendation of the healthcare they received.

Health related quality of life and Euro-Qol (EQ-5D-3L)

To evaluate differences in health-related quality of life between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Euro-Qol (EQ-5D-3L). This score ranges from 0 to 100 where 0 correlates to the worst imaginable health state whilst 100 indicates the best.

Early pain

To evaluate differences in early pain (i.e. from in-patient setting to 6-months post operation) between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through the use of a patient pain inventory form.

Early function

To evaluate differences in early function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing functional tests conducted by physiotherapists. The following functional test will be carried out on the knee joint: Range of motion

Early function

Blood loss

To compare blood loss between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining surgical data.

Adjustments to balance

To compare adjustments to balance between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining the position from the Robotic system.

Ability to reach target knee balance as assessed by alignment angles and gaps

To compare the ability to achieve soft tissue balance between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This object will be achieved by comparing pre-operative plan and pre-resection gaps with the final surgical plan and implanted gaps as derived from the robotic system. The implant position is defined as the angulation of components and resected bone in each anatomical plane. The soft tissue balance is defined as gaps created in extension and 90° of flexion when stressing the medial compartment (medial collateral ligament) and lateral compartment (lateral collateral ligament). The overall limb alignment is assessed by comparing the Hip-Knee-Ankle angle from pre-operative to 1-year post-operative on a long leg weight bearing x-ray.

Full Information

NCT ID

NCT04600583

First Posted

September 29, 2020

Last Updated

October 19, 2020

Sponsor

Stryker South Pacific

1. Study Identification

Unique Protocol Identification Number

NCT04600583

Brief Title

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

Official Title

A Prospective, Randomized, Controlled Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement - A Study Using Stryker Mako Robotic-Arm Assisted Technology®.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stryker South Pacific

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Knee, Arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alignment according to Functional Alignment philosophy

Arm Type

Active Comparator

Arm Description

Arm Title

Alignment to the patient's natural Mechanical axis

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Joint feeling and Forgotten Joint Score

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Function and Oxford Knee Score

Description

Time Frame

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

Title

Function and The International Knee Society Score

Description

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome.

Time Frame

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

Title

Function and Knee Injury and Osteoarthritis Outcome Score

Description

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms.

Time Frame

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

Title

Pain and Oxford Knee Score

Description

Time Frame

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

Title

Pain and The International Knee Society Score

Description

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome.

Time Frame

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

Title

Pain and Knee Injury and Osteoarthritis Outcome Score

Description

To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms.

Time Frame

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

Title

Pain and Visual Analogue Scale

Description

Time Frame

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

Title

Satisfaction and Net Promoter Score

Description

Time Frame

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

Title

Health related quality of life and Euro-Qol (EQ-5D-3L)

Description

Time Frame

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

Title

Early pain

Description

Time Frame

In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months

Title

Early function

Description

Time Frame

In-patient setting (< 5 days post-operation)

Title

Early function

Description

Time Frame

In-patient setting (< 5 days post-operation)

Title

Early function

Description

Time Frame

In-patient setting (< 5 days post-operation)

Title

Early function

Description

Time Frame

In-patient setting (< 5 days post-operation)

Title

Blood loss

Description

To compare blood loss between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining surgical data.

Time Frame

Intra-operative

Title

Adjustments to balance

Description

Time Frame

Intra-operative

Title

Ability to reach target knee balance as assessed by alignment angles and gaps

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Fulker, PhD

Phone

94671072

Ext

+61

david.fulker@stryker.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Young, Dr

Organizational Affiliation

North Shore Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Shore Hospital

City

Takapuna

State/Province

Auckland

ZIP/Postal Code

0622

Country

New Zealand

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simon Young, Dr

Phone

1616183

Ext

+64

simon.young@auckland.ac.nz

First Name & Middle Initial & Last Name & Degree

Matthew Walker, Dr

First Name & Middle Initial & Last Name & Degree

Bill Farrington, Dr

First Name & Middle Initial & Last Name & Degree

Ali Bayan, Dr

First Name & Middle Initial & Last Name & Degree

Rupert Van Rooyen, Dr

First Name & Middle Initial & Last Name & Degree

Simon Young, Dr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35858944

Citation

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.

Results Reference

derived

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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

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