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Trial registered on ANZCTR


Registration number
ACTRN12620000009910p
Ethics application status
Not yet submitted
Date submitted
6/12/2019
Date registered
9/01/2020
Date last updated
9/01/2020
Date data sharing statement initially provided
9/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public 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®.
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] 300028 0
None
Universal Trial Number (UTN)
Trial acronym
CAMELOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 315531 0
Condition category
Condition code
Musculoskeletal 313811 313811 0 0
Osteoarthritis
Surgery 313888 313888 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours. A mobile application (KneeBalancer) will be used to assist surgeon decision making during the dynamic joint balancing surgical step.
Intervention code [1] 316298 0
Treatment: Surgery
Intervention code [2] 316299 0
Treatment: Devices
Comparator / control treatment
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. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.
Control group
Active

Outcomes
Primary outcome [1] 322213 0
Restoration of "normal feeling" after surgery, assessed via the Forgotten Joint Score. For the purpose of this study a minimal clinically important difference of 14 points for the Forgotten Joint Score has been identified.
Timepoint [1] 322213 0
Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
Secondary outcome [1] 377971 0
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
Timepoint [1] 377971 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [2] 378096 0
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
Timepoint [2] 378096 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks and 24 months
Secondary outcome [3] 378097 0
To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: WOMAC
Timepoint [3] 378097 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [4] 378098 0
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
Timepoint [4] 378098 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [5] 378099 0
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
Timepoint [5] 378099 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks and 24 months
Secondary outcome [6] 378100 0
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: WOMAC
Timepoint [6] 378100 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [7] 378101 0
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: VAS Pain
Timepoint [7] 378101 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [8] 378102 0
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
Timepoint [8] 378102 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [9] 378103 0
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: EQ-5D
Timepoint [9] 378103 0
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [10] 378104 0
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.
Timepoint [10] 378104 0
In-patient setting, Post-operative - 6 weeks and 6 months
Secondary outcome [11] 378105 0
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
Timepoint [11] 378105 0
In-patient setting
Secondary outcome [12] 378106 0
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 employed: 9 step stair climb
Timepoint [12] 378106 0
In-patient setting
Secondary outcome [13] 378107 0
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 employed: fast paced 10m walk test
Timepoint [13] 378107 0
In-patient setting
Secondary outcome [14] 378108 0
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 employed: 30 second chair stand test
Timepoint [14] 378108 0
In-patient setting
Secondary outcome [15] 378109 0
To compare blood loss between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining surgical data
Timepoint [15] 378109 0
Intra-operative
Secondary outcome [16] 378110 0
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.
Timepoint [16] 378110 0
Intra-operative
Secondary outcome [17] 378111 0
To compare the ability to reach radiographic target between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing pre-operative plan, post-operative position (from Robotic system), AP and ML x-rays and long leg weight bearing x-rays.
Timepoint [17] 378111 0
Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months

Eligibility
Key inclusion criteria
1. Patients are male or non-pregnant females requiring a primary total knee replacement for osteoarthritis and is indicated for robotic-assisted surgery
2. The patient has intact collateral ligaments
3. The patient is able to undergo CT scanning of the affected limb
4. 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
2. Patient has had a previous osteotomy around the knee
3. The patient is morbidly obese (BMI equal to or greater than 40)
4. The patient has a deformity which will require the use of stems, wedges, or augments in conjunction with the Triathlon Total Knee System
5. The patient has a varus/valgus deformity equal to or greater than 15 degrees
6. The patient has a fixed flexion deformity equal to or greater than 15 degrees
7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration
9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements

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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22170 0
New Zealand
State/province [1] 22170 0
Auckland

Funding & Sponsors
Funding source category [1] 304480 0
Commercial sector/Industry
Name [1] 304480 0
Stryker Australia Pty Ltd
Address [1] 304480 0
8 Herbert Street
St Leonards
NSW 2065
Country [1] 304480 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd
Address
8 Herbert Street
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 304750 0
None
Name [1] 304750 0
Address [1] 304750 0
Country [1] 304750 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304914 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 304914 0
Ministry of Health
MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304914 0
New Zealand
Date submitted for ethics approval [1] 304914 0
26/01/2020
Approval date [1] 304914 0
Ethics approval number [1] 304914 0

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98626 0
Dr Simon Young
Address 98626 0
North Shore Hospital
124 Shakespeare Road
Takapuna
Auckland 0620
Country 98626 0
New Zealand
Phone 98626 0
+64 2 1616183
Fax 98626 0
Email 98626 0
simon.young@auckland.ac.nz
Contact person for public queries
Name 98627 0
Mrs Simone McLean
Address 98627 0
Stryker
8 Herbert Street
St Leonards
NSW 2065
Country 98627 0
Australia
Phone 98627 0
+61 2 94671281
Fax 98627 0
Email 98627 0
simone.mclean@stryker.com
Contact person for scientific queries
Name 98628 0
Mrs Simone McLean
Address 98628 0
Stryker
8 Herbert Street
St Leonards
NSW 2065
Country 98628 0
Australia
Phone 98628 0
+61 2 94671281
Fax 98628 0
Email 98628 0
simone.mclean@stryker.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results