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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04600583
Registration number
NCT04600583
Ethics application status
Date submitted
29/09/2020
Date registered
23/10/2020
Date last updated
23/10/2020
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
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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®.
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Secondary ID [1]
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CAMELOT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Joint feeling and Forgotten Joint Score
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Assessment method [1]
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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.
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Timepoint [1]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
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Secondary outcome [1]
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Function and Oxford Knee Score
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Assessment method [1]
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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.
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Timepoint [1]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [2]
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Function and The International Knee Society Score
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Assessment method [2]
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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.
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Timepoint [2]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
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Secondary outcome [3]
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Function and Knee Injury and Osteoarthritis Outcome Score
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Assessment method [3]
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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.
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Timepoint [3]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [4]
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Pain and Oxford Knee Score
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Assessment method [4]
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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.
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Timepoint [4]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [5]
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Pain and The International Knee Society Score
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Assessment method [5]
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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.
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Timepoint [5]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
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Secondary outcome [6]
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Pain and Knee Injury and Osteoarthritis Outcome Score
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Assessment method [6]
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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.
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Timepoint [6]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [7]
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Pain and Visual Analogue Scale
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Assessment method [7]
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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.
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Timepoint [7]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [8]
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Satisfaction and Net Promoter Score
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Assessment method [8]
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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.
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Timepoint [8]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [9]
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Health related quality of life and Euro-Qol (EQ-5D-3L)
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Assessment method [9]
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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.
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Timepoint [9]
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Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [10]
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Early pain
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Assessment method [10]
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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.
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Timepoint [10]
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In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months
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Secondary outcome [11]
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Early function
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Assessment method [11]
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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
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Timepoint [11]
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In-patient setting (< 5 days post-operation)
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Secondary outcome [12]
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Early function
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Assessment method [12]
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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
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Timepoint [12]
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In-patient setting (< 5 days post-operation)
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Secondary outcome [13]
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Early function
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Assessment method [13]
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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
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Timepoint [13]
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In-patient setting (< 5 days post-operation)
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Secondary outcome [14]
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Early function
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Assessment method [14]
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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
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Timepoint [14]
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In-patient setting (< 5 days post-operation)
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Secondary outcome [15]
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Blood loss
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Assessment method [15]
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To compare blood loss between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining surgical data.
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Timepoint [15]
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Intra-operative
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Secondary outcome [16]
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Adjustments to balance
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Assessment method [16]
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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.
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Timepoint [16]
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Intra-operative
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Secondary outcome [17]
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Ability to reach target knee balance as assessed by alignment angles and gaps
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Assessment method [17]
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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.
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Timepoint [17]
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Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months
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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.
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Minimum age
40
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/10/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2024
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Stryker South Pacific
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04600583
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Simon Young, Dr
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Address
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North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David Fulker, PhD
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Address
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Country
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Phone
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94671072
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04600583
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