Knee OsteoarthritisNCT06267482
Using ROSA for Challenging The TKA Standard of Care
A study testing ROSA PSA Parapatellar Approach and ROSA PSA Subvastus Approach in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms. 1. Standard of care medial parapetallar approach (Control) 2. ROSA PSA medial parapetallar approach 3. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ROSA PSA Parapatellar Approach and ROSA PSA Subvastus Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Who cannot join
- Active or prior infection
- Medical condition precluding major surgery
- Predominantly inflammatory arthropathy
- Patellectomy
- PCL deficiency
- Major coronal plane deformity
Show all 12Show fewer
- Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation
- Valgus alignment
- Neurologic condition limiting mobility
- Bone defects requiring augments, cones and/or stemmed implants
- Intraoperative findings of insufficient contact between the implant and the bone surface
- Body Mass Index of 40 or more
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Challenging The TKA Standard Of Care: Patient Specific Surgical Targets As Enabled By The Rosa
This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.
- Standard of care medial parapetallar approach (Control)
- ROSA PSA medial parapetallar approach
- ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.
Read the detailed description
Total knee arthroplasty (TKA) is performed to treat end-stage arthropathy of the knee with substantial increases in surgical volumes projected from the existing 750,000 surgeries performed in North America annually. The current standard of care for a primary TKA is a medial parapatellar exposure with the surgical objective of a mechanically neutral limb alignment, with the tibial component perpendicular to the anatomic axis of the tibia. As patient dissatisfaction in their TKA is substantial, surgeons, allied health care workers and patients continue to work to optimize the outcomes by tailoring surgical approaches to patient specific characteristics, with a goal to diminish early and post-operative causes of dissatisfaction. As patient-reported functional outcomes scores are an important contributor of dissatisfaction, understanding how surgical objectives and technology affect measurable functional outcomes, patient-reported outcomes, health economic and inflammatory response is important.
One of the developing thoughts in TKA surgery has been the elucidation of the range of native alignment of patients' anatomy. As placing TKA components in positions dictated by the patient's unique anatomy has garnered greater attention, literature has suggested that respecting the patient's native anatomy of joint alignment may result in equivalent or possibly improved functional outcome scores compared to neutral mechanical alignment. Simultaneously, concerns have been raised that substantial varus alignment will inadvertently occur, with resultant negative impact on longevity. A more directive patient specific alignment (PSA) concept is the anatomic alignment approach that is built around the objective of achieving a 3 degree varus joint line with respect to the mechanical axis of the leg. It is thought that this may improve patient satisfaction and function as the anatomy of the joint is preserved, including improved soft tissue balance with less soft tissue releases required. However, as conventional instrumentation is imprecise and its use can result in a range of component alignments, a surgical objective of slight varus has a substantial risk of having the implants in too great of joint line angulation resulting in reduced longevity. Improved surgical instrumentation is required to enable PSA with the objective of precisely attaining anatomic alignment to avoid the negative effect of overly varus alignment.
Zimmer-Biomet has introduced the unique ROSA orthopaedic robot. This surgical instrument will enable the surgeon to easily achieve surgical objectives with greater precision than conventional techniques. In contrast with the market leader in orthopaedic robotic assistance, the ROSA also enables the surgeon to be flexible with surgical approach and potentiate intraoperative decision making by providing greater information intra-operatively. It also enables image or imageless care pathways to enable surgeons to do surgical planning themselves to create unique surgical objectives for each patient. These market differentiating features of this orthopaedic robot advance orthopaedic care and provide the basis of expanding the orthopaedic community's understanding of PSA. The robot will also enable further challenges to the current standard of care TKA. For example, quadriceps sparing approaches such as the subvastus approach have been demonstrated to improve early functional recovery but has also been suggested to have higher rates of implant malalignment. The flexibility of approach as well as the precision of the ROSA will potentiate this approach for enhanced recovery programs, which are important in this time of increased health care burdens with limited resources as well as demands for outpatient procedures. Finally, as the Persona ® MC potentiates physiologic function of the knee with a medial pivot point rather than non-physiologic kinematics of many other TKA designs, the knee potentially will feel more physiologic. As objective and subjective functional outcomes are substantial contributors to patient dissatisfaction, understanding how patient specific alignment and soft tissue sparing approaches might improve functional outcome is critical. Wearable technology, another recent advancement within orthopaedics, has demonstrable ability to measure innumerable functional variables, and will enable a greater understanding of how the ROSA in combination with the Persona MC will lead to improved outcomes and reduced resource use.
Current literature has used inflammatory response to assess the decreased amount of soft tissue disruption after robotic versus conventional TKA. Since objective and subjective joint stiffness and reduced range of motion are common complaints among patients with suboptimal outcomes after TKA, The investigators will examine knee inflammation and fibrosis as these likely contribute to stiffness. Understanding the effect of PSA ROSA TKA with the Persona MC on local and systemic inflammation both early post-operatively as well as at one year post-operatively will be achieved by advanced imaging as well as systemic markers in the context of each individual patient's unique cellular characteristics. Our proposal will also enable quantification of how soft tissue preserving approaches affect the local inflammatory response as well as muscle atrophy or edema.
Patient reported outcome measures (PROMs) are an important subjective metric to measure surgical success and traditionally have been the primary outcome measure for many studies. However, PROMs are limited by the multi-factorial nature of the measure as well as limited responsiveness and substantial ceiling effect. The improved data collection of wearable technology has enabled differentiation of factors influencing patient satisfaction with smaller numbers of patients. Because of this, wearable technology has several advantages as a primary outcome, including the fact that wearable technology directly measures functional outcomes: a primary source of dissatisfaction after a TKA. As restoration of the patient's anatomy within defined limits should enable the implant to function with greater harmony within the envelope of static and dynamic soft tissues, functional outcomes will be the primary outcome of this proposed randomized control trial (RCT).
The investigators propose in this prospective RCT to randomize 90 patients to one of three trial arms. The control trial arm will be the standard of care TKA Persona MC and be compared to PSA ROSA TKA with the Persona MC experimental arms of two different surgical exposures. The purpose is to examine the trajectory of functional recovery as well as PROMs and inflammatory response of standard of care TKA compared to outcomes enabled by the ROSA with the objective of improving care for TKA patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- ROSA PSA Parapatellar Approach, ROSA PSA Subvastus Approach
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSA PSA Parapatellar ApproachProcedure or surgery
This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be the same as the standard of care (medial parapatellar approach).
ROSA PSA Subvastus ApproachProcedure or surgery
This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparing, subvastus approach.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care medial parapetallar approach |
| ROSA PSA Parapatellar Approach | Active comparator | Arm using the ROSA with PSA and medial parapetallar approach Receives: Procedure: ROSA PSA Parapatellar Approach |
| ROSA PSA Subvastus Approach | Active comparator | Arm using the ROSA with PSA and medial subvastus approach Receives: Procedure: ROSA PSA Subvastus Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome - Weight-bearing CT scan
Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.
Measured: Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op
Functional Outcome - 3D Ultrasound
Patients will undergo a 3D Ultrasound to measure the inflammatory characteristics including Synovial fluid and synovial thickness for fibrosis in the supra-patellar region of the knee
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Functional Outcome - Timed Up and Go test
Patients will undergo a Timed Up and Go (TUG) test. Patients will have to get up from a seated position, walk 10 feet, turn around and walk another 10 feet. This test is used to examine the function of the lower extremities. A time improvement of 2.27 Seconds will be considered clinically meaningful
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patient health status - Knee Society Score
This will be done by comparing the Knee Society Score (KSS) Patient-reported outcome measurement questionnaire given to patients. The KSS questionnaire looks at several factors such as patient satisfaction (scale from 1-5, 5 being the best), Patient expectation (scale from 1-5, 5 being the best) and patient's pain during activities (scale from No pain to severe pain)
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patient health status - EuroQuol Survey
This will be done by comparing the EuroQuol (EQ-5D) Patient-reported outcome measurement questionnaire given to patients. EQ-5D looks at the overall quality of life of a patient. The survey has 2 sections, the first asking the patient to best describe their health (Scale from Unable to perform the activity to no problem performing the activity) and an overall health assessment (scale 0-100, 100 being the best health you can imagine)
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patient health status - Knee Injury and Osteoarthritis Outcome Score
This will be done by comparing the Knee Injury and Osteoarthritis Outcome score (KOOS) Patient-reported outcome measurement questionnaire given to patients. The KOOS survey looks at the pain and function of the operated knee. Patients will be asked questions about the pain they feel during activities (Scale from none-extreme) and the function of their joint (scale from none-extreme)
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patient health status - Western Ontario and McMaster Universities Arthritis Index
This will be done by comparing the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Patient-reported outcome measurement questionnaire given to patients. This survey will ask patients about the pain, stiffness and difficulty of using their knee. This survey is scaled from 0-4, 0 being none and 4 being extreme.
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patient health status - Global Assessment
This will be done by comparing the UCLA Activity Score (UCLA) Patient-reported outcome measurement questionnaire given to patients. This survey assesses the activity level of patients on a scale from 0 - 10 with 10 being the patient regularly participates in impact sports.
Measured: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Secondary outcomes (1)
Health Ecominics
Patients will be asked to fill out a cost-diary to determine if the new methods help reduce resource consumption
Measured: Pre-operation, 1-3 days post-op, 6-weeks post-op, 3-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start16 Apr 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Brent Lanting, PhD, Principal investigator, London Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267482
- Sponsor's protocol ID
- 122311
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS. Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. Bone Joint J. 2014 Jul;96-B(7):857-62. doi: 10.1302/0301-620X.96B7.33946.
PubMed 24986936Lanting BA, Lieberman JR, Callaghan JJ, Berend ME, MacDonald SJ. Ensuring a Winner: The ABCs of Primary Total Knee Arthroplasty. Instr Course Lect. 2015;64:369-79.
PubMed 25745921Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
PubMed 24187375Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.
PubMed 28844632Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
PubMed 16967035Vandekerckhove PTK, Matlovich N, Teeter MG, MacDonald SJ, Howard JL, Lanting BA. The relationship between constitutional alignment and varus osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2873-2879. doi: 10.1007/s00167-016-3994-4. Epub 2016 Feb 1.
PubMed 26831863Lanting BA, Williams HA, Matlovich NF, Vandekerckhove PJ, Teeter MG, Vasarhelyi EM, Howard JL, Somerville LE. The impact of residual varus alignment following total knee arthroplasty on patient outcome scores in a constitutional varus population. Knee. 2018 Dec;25(6):1278-1282. doi: 10.1016/j.knee.2018.08.019. Epub 2018 Oct 9.
PubMed 30314879Howell SM, Hodapp EE, Vernace JV, Hull ML, Meade TD. Are undesirable contact kinematics minimized after kinematically aligned total knee arthroplasty? An intersurgeon analysis of consecutive patients. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2281-7. doi: 10.1007/s00167-012-2220-2. Epub 2012 Oct 2.
PubMed 23052114Howell SM, Howell SJ, Kuznik KT, Cohen J, Hull ML. Does a kinematically aligned total knee arthroplasty restore function without failure regardless of alignment category? Clin Orthop Relat Res. 2013 Mar;471(3):1000-7. doi: 10.1007/s11999-012-2613-z. Epub 2012 Sep 21.
PubMed 22996362Howell SM, Papadopoulos S, Kuznik KT, Hull ML. Accurate alignment and high function after kinematically aligned TKA performed with generic instruments. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2271-80. doi: 10.1007/s00167-013-2621-x. Epub 2013 Aug 15.
PubMed 23948721Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
PubMed 24986944Dossett HG, Swartz GJ, Estrada NA, LeFevre GW, Kwasman BG. Kinematically versus mechanically aligned total knee arthroplasty. Orthopedics. 2012 Feb 17;35(2):e160-9. doi: 10.3928/01477447-20120123-04.
PubMed 22310400Fang D, Ritter MA. Malalignment: forewarned is forearmed. Orthopedics. 2009 Sep;32(9):orthosupersite.com/view.asp?rID=42850. doi: 10.3928/01477447-20090728-29.
PubMed 19751003
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenging The TKA Standard Of Care: Patient Specific Surgical Targets As Enabled By The Rosa
- ClinicalTrials.gov ID
- NCT06267482
- Acronym / sponsor ID
- 122311
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.
- Standard of care medial parapetallar approach (Control)
- ROSA PSA medial parapetallar approach
- ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.
Detailed description
Total knee arthroplasty (TKA) is performed to treat end-stage arthropathy of the knee with substantial increases in surgical volumes projected from the existing 750,000 surgeries performed in North America annually. The current standard of care for a primary TKA is a medial parapatellar exposure with the surgical objective of a mechanically neutral limb alignment, with the tibial component perpendicular to the anatomic axis of the tibia. As patient dissatisfaction in their TKA is substantial, surgeons, allied health care workers and patients continue to work to optimize the outcomes by tailoring surgical approaches to patient specific characteristics, with a goal to diminish early and post-operative causes of dissatisfaction. As patient-reported functional outcomes scores are an important contributor of dissatisfaction, understanding how surgical objectives and technology affect measurable functional outcomes, patient-reported outcomes, health economic and inflammatory response is important.
One of the developing thoughts in TKA surgery has been the elucidation of the range of native alignment of patients' anatomy. As placing TKA components in positions dictated by the patient's unique anatomy has garnered greater attention, literature has suggested that respecting the patient's native anatomy of joint alignment may result in equivalent or possibly improved functional outcome scores compared to neutral mechanical alignment. Simultaneously, concerns have been raised that substantial varus alignment will inadvertently occur, with resultant negative impact on longevity. A more directive patient specific alignment (PSA) concept is the anatomic alignment approach that is built around the objective of achieving a 3 degree varus joint line with respect to the mechanical axis of the leg. It is thought that this may improve patient satisfaction and function as the anatomy of the joint is preserved, including improved soft tissue balance with less soft tissue releases required. However, as conventional instrumentation is imprecise and its use can result in a range of component alignments, a surgical objective of slight varus has a substantial risk of having the implants in too great of joint line angulation resulting in reduced longevity. Improved surgical instrumentation is required to enable PSA with the objective of precisely attaining anatomic alignment to avoid the negative effect of overly varus alignment.
Zimmer-Biomet has introduced the unique ROSA orthopaedic robot. This surgical instrument will enable the surgeon to easily achieve surgical objectives with greater precision than conventional techniques. In contrast with the market leader in orthopaedic robotic assistance, the ROSA also enables the surgeon to be flexible with surgical approach and potentiate intraoperative decision making by providing greater information intra-operatively. It also enables image or imageless care pathways to enable surgeons to do surgical planning themselves to create unique surgical objectives for each patient. These market differentiating features of this orthopaedic robot advance orthopaedic care and provide the basis of expanding the orthopaedic community's understanding of PSA. The robot will also enable further challenges to the current standard of care TKA. For example, quadriceps sparing approaches such as the subvastus approach have been demonstrated to improve early functional recovery but has also been suggested to have higher rates of implant malalignment. The flexibility of approach as well as the precision of the ROSA will potentiate this approach for enhanced recovery programs, which are important in this time of increased health care burdens with limited resources as well as demands for outpatient procedures. Finally, as the Persona ® MC potentiates physiologic function of the knee with a medial pivot point rather than non-physiologic kinematics of many other TKA designs, the knee potentially will feel more physiologic. As objective and subjective functional outcomes are substantial contributors to patient dissatisfaction, understanding how patient specific alignment and soft tissue sparing approaches might improve functional outcome is critical. Wearable technology, another recent advancement within orthopaedics, has demonstrable ability to measure innumerable functional variables, and will enable a greater understanding of how the ROSA in combination with the Persona MC will lead to improved outcomes and reduced resource use.
Current literature has used inflammatory response to assess the decreased amount of soft tissue disruption after robotic versus conventional TKA. Since objective and subjective joint stiffness and reduced range of motion are common complaints among patients with suboptimal outcomes after TKA, The investigators will examine knee inflammation and fibrosis as these likely contribute to stiffness. Understanding the effect of PSA ROSA TKA with the Persona MC on local and systemic inflammation both early post-operatively as well as at one year post-operatively will be achieved by advanced imaging as well as systemic markers in the context of each individual patient's unique cellular characteristics. Our proposal will also enable quantification of how soft tissue preserving approaches affect the local inflammatory response as well as muscle atrophy or edema.
Patient reported outcome measures (PROMs) are an important subjective metric to measure surgical success and traditionally have been the primary outcome measure for many studies. However, PROMs are limited by the multi-factorial nature of the measure as well as limited responsiveness and substantial ceiling effect. The improved data collection of wearable technology has enabled differentiation of factors influencing patient satisfaction with smaller numbers of patients. Because of this, wearable technology has several advantages as a primary outcome, including the fact that wearable technology directly measures functional outcomes: a primary source of dissatisfaction after a TKA. As restoration of the patient's anatomy within defined limits should enable the implant to function with greater harmony within the envelope of static and dynamic soft tissues, functional outcomes will be the primary outcome of this proposed randomized control trial (RCT).
The investigators propose in this prospective RCT to randomize 90 patients to one of three trial arms. The control trial arm will be the standard of care TKA Persona MC and be compared to PSA ROSA TKA with the Persona MC experimental arms of two different surgical exposures. The purpose is to examine the trajectory of functional recovery as well as PROMs and inflammatory response of standard of care TKA compared to outcomes enabled by the ROSA with the objective of improving care for TKA patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care medial parapetallar approach |
| ROSA PSA Parapatellar Approach | Active comparator | Procedure: ROSA PSA Parapatellar ApproachArm using the ROSA with PSA and medial parapetallar approach |
| ROSA PSA Subvastus Approach | Active comparator | Procedure: ROSA PSA Subvastus ApproachArm using the ROSA with PSA and medial subvastus approach |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
Key exclusion criteria (12 listed)
- Active or prior infection
- Medical condition precluding major surgery
- Predominantly inflammatory arthropathy
- Patellectomy
- PCL deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROSA PSA Parapatellar ApproachThis intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be the same as the standard of care (medial parapatellar approach). | Procedure or surgery | ROSA PSA Parapatellar Approach |
| ROSA PSA Subvastus ApproachThis intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparing, subvastus approach. | Procedure or surgery | ROSA PSA Subvastus Approach |
Primary outcome
Functional Outcome - Weight-bearing CT scan
Time frame: Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op
Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.
Functional Outcome - 3D Ultrasound
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patients will undergo a 3D Ultrasound to measure the inflammatory characteristics including Synovial fluid and synovial thickness for fibrosis in the supra-patellar region of the knee
Functional Outcome - Timed Up and Go test
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Patients will undergo a Timed Up and Go (TUG) test. Patients will have to get up from a seated position, walk 10 feet, turn around and walk another 10 feet. This test is used to examine the function of the lower extremities. A time improvement of 2.27 Seconds will be considered clinically meaningful
Patient health status - Knee Society Score
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
This will be done by comparing the Knee Society Score (KSS) Patient-reported outcome measurement questionnaire given to patients. The KSS questionnaire looks at several factors such as patient satisfaction (scale from 1-5, 5 being the best), Patient expectation (scale from 1-5, 5 being the best) and patient's pain during activities (scale from No pain to severe pain)
Patient health status - EuroQuol Survey
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
This will be done by comparing the EuroQuol (EQ-5D) Patient-reported outcome measurement questionnaire given to patients. EQ-5D looks at the overall quality of life of a patient. The survey has 2 sections, the first asking the patient to best describe their health (Scale from Unable to perform the activity to no problem performing the activity) and an overall health assessment (scale 0-100, 100 being the best health you can imagine)
Patient health status - Knee Injury and Osteoarthritis Outcome Score
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
This will be done by comparing the Knee Injury and Osteoarthritis Outcome score (KOOS) Patient-reported outcome measurement questionnaire given to patients. The KOOS survey looks at the pain and function of the operated knee. Patients will be asked questions about the pain they feel during activities (Scale from none-extreme) and the function of their joint (scale from none-extreme)
Patient health status - Western Ontario and McMaster Universities Arthritis Index
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
This will be done by comparing the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Patient-reported outcome measurement questionnaire given to patients. This survey will ask patients about the pain, stiffness and difficulty of using their knee. This survey is scaled from 0-4, 0 being none and 4 being extreme.
Patient health status - Global Assessment
Time frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
This will be done by comparing the UCLA Activity Score (UCLA) Patient-reported outcome measurement questionnaire given to patients. This survey assesses the activity level of patients on a scale from 0 - 10 with 10 being the patient regularly participates in impact sports.
1 secondary outcome
Health Ecominics
Time frame: Pre-operation, 1-3 days post-op, 6-weeks post-op, 3-months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 24986936Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS. Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. Bone Joint J. 2014 Jul;96-B(7):857-62. doi: 10.1302/0301-620X.96B7.33946.
- Background: PubMed 25745921Lanting BA, Lieberman JR, Callaghan JJ, Berend ME, MacDonald SJ. Ensuring a Winner: The ABCs of Primary Total Knee Arthroplasty. Instr Course Lect. 2015;64:369-79.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 24187375Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
- Background: PubMed 28844632Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.
- Background: PubMed 16967035Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
- Background: PubMed 26831863Vandekerckhove PTK, Matlovich N, Teeter MG, MacDonald SJ, Howard JL, Lanting BA. The relationship between constitutional alignment and varus osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2873-2879. doi: 10.1007/s00167-016-3994-4. Epub 2016 Feb 1.
- Background: PubMed 30314879Lanting BA, Williams HA, Matlovich NF, Vandekerckhove PJ, Teeter MG, Vasarhelyi EM, Howard JL, Somerville LE. The impact of residual varus alignment following total knee arthroplasty on patient outcome scores in a constitutional varus population. Knee. 2018 Dec;25(6):1278-1282. doi: 10.1016/j.knee.2018.08.019. Epub 2018 Oct 9.
- Background: PubMed 23052114Howell SM, Hodapp EE, Vernace JV, Hull ML, Meade TD. Are undesirable contact kinematics minimized after kinematically aligned total knee arthroplasty? An intersurgeon analysis of consecutive patients. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2281-7. doi: 10.1007/s00167-012-2220-2. Epub 2012 Oct 2.
- Background: PubMed 22996362Howell SM, Howell SJ, Kuznik KT, Cohen J, Hull ML. Does a kinematically aligned total knee arthroplasty restore function without failure regardless of alignment category? Clin Orthop Relat Res. 2013 Mar;471(3):1000-7. doi: 10.1007/s11999-012-2613-z. Epub 2012 Sep 21.
- Background: PubMed 23948721Howell SM, Papadopoulos S, Kuznik KT, Hull ML. Accurate alignment and high function after kinematically aligned TKA performed with generic instruments. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2271-80. doi: 10.1007/s00167-013-2621-x. Epub 2013 Aug 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brent Lanting, PhD principal investigator
London Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSA PSA Parapatellar Approach and ROSA PSA Subvastus Approach in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyndsay Somerville, PhD ((519) 685-8500 ext. 36645, lyndsay.somerville@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome - Weight-bearing CT scan (time frame: Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06267482, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.