An interventional study of Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) in Osteoarthritis, sponsored by Stryker South Pacific. Active, not recruiting at 1 site in New Zealand. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Stryker South Pacific · Not applicable, Interventional, and Treatment
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 278 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Stryker South Pacific is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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)
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)
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.
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
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.
Time frame: 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
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
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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.
Time frame: 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
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
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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.
Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
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.
Time frame: In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months
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
Time frame: In-patient setting (< 5 days post-operation)
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 employed: 9 step stair climb
Time frame: In-patient setting (< 5 days post-operation)
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 employed: fast paced 10m walk test
Time frame: In-patient setting (< 5 days post-operation)
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 employed: 30 second chair stand test
Time frame: In-patient setting (< 5 days post-operation)
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.
Time frame: Intra-operative
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.
Time frame: Intra-operative
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.
Time frame: Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months
Plan to share: No
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Stryker South Pacific