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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04600583




Registration number
NCT04600583
Ethics application status
Date submitted
29/09/2020
Date registered
23/10/2020
Date last updated
23/07/2024

Titles & IDs
Public 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
Scientific 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®.
Secondary ID [1] 0 0
CAMELOT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)

Active comparator: 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.

Active comparator: 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.


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Joint feeling and Forgotten Joint Score
Timepoint [1] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
Secondary outcome [1] 0 0
Function and Oxford Knee Score
Timepoint [1] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [2] 0 0
Function and The International Knee Society Score
Timepoint [2] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
Secondary outcome [3] 0 0
Function and Knee Injury and Osteoarthritis Outcome Score
Timepoint [3] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [4] 0 0
Pain and Oxford Knee Score
Timepoint [4] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [5] 0 0
Pain and The International Knee Society Score
Timepoint [5] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
Secondary outcome [6] 0 0
Pain and Knee Injury and Osteoarthritis Outcome Score
Timepoint [6] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [7] 0 0
Pain and Visual Analogue Scale
Timepoint [7] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [8] 0 0
Satisfaction and Net Promoter Score
Timepoint [8] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [9] 0 0
Health related quality of life and Euro-Qol (EQ-5D-3L)
Timepoint [9] 0 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [10] 0 0
Early pain
Timepoint [10] 0 0
In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months
Secondary outcome [11] 0 0
Early function
Timepoint [11] 0 0
In-patient setting (< 5 days post-operation)
Secondary outcome [12] 0 0
Early function
Timepoint [12] 0 0
In-patient setting (< 5 days post-operation)
Secondary outcome [13] 0 0
Early function
Timepoint [13] 0 0
In-patient setting (< 5 days post-operation)
Secondary outcome [14] 0 0
Early function
Timepoint [14] 0 0
In-patient setting (< 5 days post-operation)
Secondary outcome [15] 0 0
Blood loss
Timepoint [15] 0 0
Intra-operative
Secondary outcome [16] 0 0
Adjustments to balance
Timepoint [16] 0 0
Intra-operative
Secondary outcome [17] 0 0
Ability to reach target knee balance as assessed by alignment angles and gaps
Timepoint [17] 0 0
Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stryker South Pacific
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04600583
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Simon Young, Dr
Address 0 0
North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Fulker, PhD
Address 0 0
Country 0 0
Phone 0 0
94671072
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04600583