Using ROSA for Challenging The TKA Standard of Care

Knee Osteoarthritis Clinical Trial

Official title:

Challenging The TKA Standard Of Care: Patient Specific Surgical Targets As Enabled By The Rosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267482
• Other study ID #: 122311
• Status: Recruiting
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Lawson Health Research Institute
• Contact: Lyndsay Somerville, PhD
• Phone: (519) 685-8500
• Email: lyndsay.somerville[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Active or prior infection

• Medical condition precluding major surgery

• Predominantly inflammatory arthropathy

• Patellectomy

• PCL deficiency

• Major coronal plane deformity

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• ROSA PSA Parapatellar Approach
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 Approach
This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparring, subvastus approach.

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Zimmer Biomet

Country where clinical trial is conducted

Canada, 

References & Publications (28)

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Lanting 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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome - Weight-bearing CT scan	Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.	Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op
Primary	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	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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)	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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)	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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)	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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.	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Primary	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.	Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Secondary	Health Ecominics	Patients will be asked to fill out a cost-diary to determine if the new methods help reduce resource consumption	Pre-operation, 1-3 days post-op, 6-weeks post-op, 3-months post-op