Knee OsteoarthritisNCT05629715
Conventional Instrumentation, Computer Navigation, and Robotic Assistance Techniques in TKA
A study testing ROSA Knee System and KneeAlign Computer Assisted Navigation System in people with Knee Osteoarthritis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Knee osteoarthritis is a debilitating disease that can cause severe knee pain and significant limitations to patients' activities of daily living. Total knee arthroplasty (TKA), also known as knee replacement surgery, is a well-established and successful procedure for treatment of end-stage knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ROSA Knee System and KneeAlign Computer Assisted Navigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is a minimum of 18 years of age
- Independent of study participation, patient is a candidate for commercially available Persona or Legion knee components implanted in accordance with product labeling
- Patient has participated in this study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee (EC) approved Informed Consent form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
Who cannot join
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient has undergone contralateral unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA) within the last 18 months
- Hip pathology with significant bone loss (e.g., avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
- Hip pathology severely limiting range of motion (e.g., arthrodesis, severe contracture, chronic severe dislocation)
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
- Patients with active knee joint infections (determined clinically at time of pre-op evaluation)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Santa Monica Medical Center
Santa Monica, California, 90404
About this study
Official title: A Prospective, Randomized, Unblinded Trial Comparing Conventional Instrumentation, Hand-Held Accelerometer Based Computer Navigation, and Robotic Assistance Techniques in Total Knee Arthroplasty
Knee osteoarthritis is a debilitating disease that can cause severe knee pain and significant limitations to patients' activities of daily living. Total knee arthroplasty (TKA), also known as knee replacement surgery, is a well-established and successful procedure for treatment of end-stage knee osteoarthritis. Over the years, TKA surgical techniques and implant technology have improved, resulting in better patient outcomes and implant survivorship. Despite continuous improvements being made to this high demand procedure, malalignment of component position is a well-known cause of post-operative complications, including knee pain, component loosening, and failure requiring revision surgery.
Advanced techniques that utilize computer navigation or robotic-arm assistance have been developed in an attempt to avoid malalignment. Both technologies were created with the goal of improving the precision of implant positioning and implant sizing in order to improve lower limb alignment and joint line alignment. The OrthoAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position. The Zimmer Biomet ROSA Knee System is a commercially available, FDA-approved robotic assistant for performing TKA. It uses pre-operative x-rays to create a three-dimensional image of the patient's knee anatomy, which is used to create a pre-operative template of the implants to be used and provides intra-operative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks. To date, there have been no prospective studies comparing the implant positioning and patient outcomes directly of the KneeAlign system with the ROSA system and conventional TKA instrumentation techniques.
Read the detailed description
This is a prospective, single center, unblinded, randomized clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, adverse event data, and radiographic outcomes for patients undergoing TKA with one of three instrumentation techniques. This clinical study will include Persona and Legion product families using the ROSA Knee System, KneeAlign navigation system, or conventional instrumentation.
The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Knee System instrumentation or OrthAlign KneeAlign system compared with conventional TKA instrumentation. The hypothesis is that the ROSA Knee System and KneeAlign system will demonstrate greater accuracy and more consistent component position and greater patient reported outcome scores compared to conventional TKA surgery. The investigators suspect that the ROSA system may be more accurate and precise than the KneeAlign system.
A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the investigator will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in a 1:1:1 ratio. The subject will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms. The Principal Investigator and Co-Investigators will be skilled in TKA and experienced implanting Persona or Legion TKA system. Two of the investigators will only be using the Persona TKA system as this is their current standard of practice. One of the other investigators will use the Legion TKA system as this is their standard of practice. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the aforementioned implants. All study subjects will undergo preoperative clinical evaluations prior to their TKA.
An a priori power analysis was conducted using G*Power 3.1 Data Analysis program to determine the sample size based on a Cohen's f-statistic of 0.25. Power was set at 0.95 and with an alpha of 0.05. Total sample size based on these parameters was 252 patients. Considering that three surgeons, who perform approximately 250 TKAs per year each, will be involved, the investigators estimate that an ability to enroll approximately one-third of all eligible patients seeking TKA and, thus, set a goal for 300 patients to account for patient attrition after study initiation.
Through the use of either conventional, computer navigated or robotic techniques, standard operating procedures will be followed and all surgical procedures will be performed under aseptic conditions. Investigators will implant all commercially available components in compliance with corresponding labeling requirements, and in accordance with appropriate surgical technique(s).
Post-surgical management for study subjects will follow the investigator's standard of care for patients undergoing TKA (e.g., prophylactic antibiotic therapy, prevention of deep vein thrombosis, prevention of pulmonary embolism, etc.). Post-surgical rehabilitative therapy will be as prescribed by the investigator. Post-operative clinical evaluation will be conducted at approximately 6 weeks, 3 months, 6 months and 1 year post-operatively. Subjects will be followed post-operatively for 1 year.
- Conditions
- Knee Osteoarthritis
- Being tested
- ROSA Knee System, KneeAlign Computer Assisted Navigation System
- 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 Knee SystemDevice
The Zimmer Biomet ROSA Knee System is a commercially available, FDA approved robotic assistant for performing TKA. It uses preoperative x-rays to create a three-dimensional image of the patient's knee anatomy which is used to create a preoperative template of the implants to be used and provides intraoperative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks.
KneeAlign Computer Assisted Navigation SystemDevice
The OrthAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position.
| Study group | Role | What they receive |
|---|---|---|
| ROSA | Active comparator | Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the ROSA Knee System. Receives: Device: ROSA Knee System |
| KneeAlign | Active comparator | Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the KneeAlign navigation system. Receives: Device: KneeAlign Computer Assisted Navigation System |
| Conventional | No intervention | Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using conventional instrumentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: Pre-Op
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: Up to 6 Hours
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: 6 weeks
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: 3 months
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: 6 months
Implant Positioning
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Measured: 1 year
Secondary outcomes (41)
Knee Questionnaire
Forgotten Joint Score - 12 questions scored 1 (never) to 5 (mostly). The 12 scores are aggregated to a raw score from 12-60. This raw score is linearly transformed to a 0-100 scale and then reversed to obtain a final score. A high final score indicates a good outcome.
Measured: Pre-Op
Knee Outcome Score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) - 7 questions scored from 0 (none) to 4 (extreme). The 7 scores are aggregated to a score from 0-28 which inversely equates to an interval score of 0-100. An interval score of 0 equates to total knee disability and an interval score of 100 indicates perfect knee health.
Measured: Pre-Op
Health Questionnaire
EuroQol-5 Dimensions-5 Level (EQ-5D-5L) - This consists of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises five questions, scored 1 (no problems) to 5 (extreme problems). The score for each question can be combined into a 5-digit number that describes the patient's health state. A score of 11111 would be optimal. A score of 55555 would equate to complete disability. The VAS is a self-rated vertical scale, from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Measured: Pre-Op
Objective Knee Assessment
Charnley Functional Classification - An objective knee indicator with 6 possible classifications: Unilateral Knee Arthritis; Unilateral Total Knee Arthroplasty (TKA), opposite knee arthritic; Bilateral TKA; TKA, but remote arthritis affecting ambulation; TKA, but medical condition affecting ambulation; Unilateral or Bilateral TKA with unilateral or bilateral Total Hip Arthroplasty.
Measured: Pre-Op
Knee Alignment
Anatomic alignment measured on Anterior Posterior (AP) Standing x-ray
Measured: Pre-Op
Knee Instability Medial/Lateral (M/L)
M/L instability measured in full extension
Measured: Pre-Op
Knee Instability Anterior/Posterior (A/P)
A/P instability measured at 90 degrees
Measured: Pre-Op
Joint Motion
Knee Range of Motion measured in degrees
Measured: Pre-Op
Knee Questionnaire
Forgotten Joint Score - 12 questions scored 1 (never) to 5 (mostly). The 12 scores are aggregated to a raw score from 12-60. This raw score is linearly transformed to a 0-100 scale and then reversed to obtain a final score. A high final score indicates a good outcome.
Measured: 6 weeks
Knee Outcome Score
KOOS, JR. - 7 questions scored from 0 (none) to 4 (extreme). The 7 scores are aggregated to a score from 0-28 which inversely equates to an interval score of 0-100. An interval score of 0 equates to total knee disability and an interval score of 100 indicates perfect knee health.
Measured: 6 weeks
Health Questionnaire
EQ-5D-5L - This consists of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises five questions, scored 1 (no problems) to 5 (extreme problems). The score for each question can be combined into a 5-digit number that describes the patient's health state. A score of 11111 would be optimal. A score of 55555 would equate to complete disability. The VAS is a self-rated vertical scale, from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Measured: 6 weeks
Objective Knee Assessment
Charnley Functional Classification - An objective knee indicator with 6 possible classifications: Unilateral Knee Arthritis; Unilateral Total Knee Arthroplasty (TKA), opposite knee arthritic; Bilateral TKA; TKA, but remote arthritis affecting ambulation; TKA, but medical condition affecting ambulation; Unilateral or Bilateral TKA with unilateral or bilateral Total Hip Arthroplasty.
Measured: 6 weeks
Knee Alignment
Anatomic alignment measured on AP Standing x-ray
Measured: 6 weeks
Knee Instability M/L
M/L instability measured in full extension
Measured: 6 weeks
Knee Instability A/P
A/P instability measured at 90 degrees
Measured: 6 weeks
Joint Motion
Knee Range of Motion measured in degrees
Measured: 6 weeks
Patellar Tracking
Investigator assessment of any abnormalities in patellar tracking post-operatively
Measured: 6 weeks
Patient Satisfaction
Question to be completed by the subject indicating their level of satisfaction with the operated knee as either Very Satisfied, Satisfied, Uncertain, or Unsatisfied.
Measured: 6 weeks
Knee Questionnaire
Forgotten Joint Score - 12 questions scored 1 (never) to 5 (mostly). The 12 scores are aggregated to a raw score from 12-60. This raw score is linearly transformed to a 0-100 scale and then reversed to obtain a final score. A high final score indicates a good outcome.
Measured: 3 months
Knee Outcome Score
KOOS, JR. - 7 questions scored from 0 (none) to 4 (extreme). The 7 scores are aggregated to a score from 0-28 which inversely equates to an interval score of 0-100. An interval score of 0 equates to total knee disability and an interval score of 100 indicates perfect knee health.
Measured: 3 months
Health Questionnaire
EQ-5D-5L - This consists of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises five questions, scored 1 (no problems) to 5 (extreme problems). The score for each question can be combined into a 5-digit number that describes the patient's health state. A score of 11111 would be optimal. A score of 55555 would equate to complete disability. The VAS is a self-rated vertical scale, from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Measured: 3 months
Objective Knee Assessment
Charnley Functional Classification - An objective knee indicator with 6 possible classifications: Unilateral Knee Arthritis; Unilateral Total Knee Arthroplasty (TKA), opposite knee arthritic; Bilateral TKA; TKA, but remote arthritis affecting ambulation; TKA, but medical condition affecting ambulation; Unilateral or Bilateral TKA with unilateral or bilateral Total Hip Arthroplasty.
Measured: 3 months
Knee Alignment
Anatomic alignment measured on AP Standing x-ray
Measured: 3 months
Knee Instability M/L
M/L instability measured in full extension
Measured: 3 months
Knee Instability A/P
A/P instability measured at 90 degrees
Measured: 3 months
Joint Motion
Knee Range of Motion measured in degrees
Measured: 3 months
Patellar Tracking
Investigator assessment of any abnormalities in patellar tracking post-operatively
Measured: 3 months
Patient Satisfaction
Question to be completed by the subject indicating their level of satisfaction with the operated knee as either Very Satisfied, Satisfied, Uncertain, or Unsatisfied.
Measured: 3 months
Knee Questionnaire
Forgotten Joint Score - 12 questions scored 1 (never) to 5 (mostly). The 12 scores are aggregated to a raw score from 12-60. This raw score is linearly transformed to a 0-100 scale and then reversed to obtain a final score. A high final score indicates a good outcome.
Measured: 6 months
Knee Outcome Score
KOOS, JR. - 7 questions scored from 0 (none) to 4 (extreme). The 7 scores are aggregated to a score from 0-28 which inversely equates to an interval score of 0-100. An interval score of 0 equates to total knee disability and an interval score of 100 indicates perfect knee health.
Measured: 6 months
Health Questionnaire
EQ-5D-5L - This consists of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises five questions, scored 1 (no problems) to 5 (extreme problems). The score for each question can be combined into a 5-digit number that describes the patient's health state. A score of 11111 would be optimal. A score of 55555 would equate to complete disability. The VAS is a self-rated vertical scale, from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Measured: 6 months
Knee Questionnaire
Forgotten Joint Score - 12 questions scored 1 (never) to 5 (mostly). The 12 scores are aggregated to a raw score from 12-60. This raw score is linearly transformed to a 0-100 scale and then reversed to obtain a final score. A high final score indicates a good outcome.
Measured: 1 year
Knee Outcome Score
KOOS, JR. - 7 questions scored from 0 (none) to 4 (extreme). The 7 scores are aggregated to a score from 0-28 which inversely equates to an interval score of 0-100. An interval score of 0 equates to total knee disability and an interval score of 100 indicates perfect knee health.
Measured: 1 year
Health Questionnaire
EQ-5D-5L - This consists of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises five questions, scored 1 (no problems) to 5 (extreme problems). The score for each question can be combined into a 5-digit number that describes the patient's health state. A score of 11111 would be optimal. A score of 55555 would equate to complete disability. The VAS is a self-rated vertical scale, from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Measured: 1 year
Objective Knee Assessment
Charnley Functional Classification - An objective knee indicator with 6 possible classifications: Unilateral Knee Arthritis; Unilateral Total Knee Arthroplasty (TKA), opposite knee arthritic; Bilateral TKA; TKA, but remote arthritis affecting ambulation; TKA, but medical condition affecting ambulation; Unilateral or Bilateral TKA with unilateral or bilateral Total Hip Arthroplasty.
Measured: 1 year
Knee Alignment
Anatomic alignment measured on AP Standing x-ray
Measured: 1 year
Knee Instability M/L
M/L instability measured in full extension
Measured: 1 year
Knee Instability A/P
A/P instability measured at 90 degrees
Measured: 1 year
Joint Motion
Knee Range of Motion measured in degrees
Measured: 1 year
Patellar Tracking
Investigator assessment of any abnormalities in patellar tracking post-operatively
Measured: 1 year
Patient Satisfaction
Question to be completed by the subject indicating their level of satisfaction with the operated knee as either Very Satisfied, Satisfied, Uncertain, or Unsatisfied.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the surgeon will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in Microsoft Excel in a 1:1:1 ratio. The patient will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik N. Zeegen, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629715
- Sponsor's protocol ID
- IRB#21-002140
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Unblinded Trial Comparing Conventional Instrumentation, Hand-Held Accelerometer Based Computer Navigation, and Robotic Assistance Techniques in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05629715
- Acronym / sponsor ID
- IRB#21-002140
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Nov 2022 (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.
Knee osteoarthritis is a debilitating disease that can cause severe knee pain and significant limitations to patients' activities of daily living. Total knee arthroplasty (TKA), also known as knee replacement surgery, is a well-established and successful procedure for treatment of end-stage knee osteoarthritis. Over the years, TKA surgical techniques and implant technology have improved, resulting in better patient outcomes and implant survivorship. Despite continuous improvements being made to this high demand procedure, malalignment of component position is a well-known cause of post-operative complications, including knee pain, component loosening, and failure requiring revision surgery.
Advanced techniques that utilize computer navigation or robotic-arm assistance have been developed in an attempt to avoid malalignment. Both technologies were created with the goal of improving the precision of implant positioning and implant sizing in order to improve lower limb alignment and joint line alignment. The OrthoAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position. The Zimmer Biomet ROSA Knee System is a commercially available, FDA-approved robotic assistant for performing TKA. It uses pre-operative x-rays to create a three-dimensional image of the patient's knee anatomy, which is used to create a pre-operative template of the implants to be used and provides intra-operative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks. To date, there have been no prospective studies comparing the implant positioning and patient outcomes directly of the KneeAlign system with the ROSA system and conventional TKA instrumentation techniques.
Detailed description
This is a prospective, single center, unblinded, randomized clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, adverse event data, and radiographic outcomes for patients undergoing TKA with one of three instrumentation techniques. This clinical study will include Persona and Legion product families using the ROSA Knee System, KneeAlign navigation system, or conventional instrumentation.
The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Knee System instrumentation or OrthAlign KneeAlign system compared with conventional TKA instrumentation. The hypothesis is that the ROSA Knee System and KneeAlign system will demonstrate greater accuracy and more consistent component position and greater patient reported outcome scores compared to conventional TKA surgery. The investigators suspect that the ROSA system may be more accurate and precise than the KneeAlign system.
A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the investigator will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in a 1:1:1 ratio. The subject will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms. The Principal Investigator and Co-Investigators will be skilled in TKA and experienced implanting Persona or Legion TKA system. Two of the investigators will only be using the Persona TKA system as this is their current standard of practice. One of the other investigators will use the Legion TKA system as this is their standard of practice. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the aforementioned implants. All study subjects will undergo preoperative clinical evaluations prior to their TKA.
An a priori power analysis was conducted using G*Power 3.1 Data Analysis program to determine the sample size based on a Cohen's f-statistic of 0.25. Power was set at 0.95 and with an alpha of 0.05. Total sample size based on these parameters was 252 patients. Considering that three surgeons, who perform approximately 250 TKAs per year each, will be involved, the investigators estimate that an ability to enroll approximately one-third of all eligible patients seeking TKA and, thus, set a goal for 300 patients to account for patient attrition after study initiation.
Through the use of either conventional, computer navigated or robotic techniques, standard operating procedures will be followed and all surgical procedures will be performed under aseptic conditions. Investigators will implant all commercially available components in compliance with corresponding labeling requirements, and in accordance with appropriate surgical technique(s).
Post-surgical management for study subjects will follow the investigator's standard of care for patients undergoing TKA (e.g., prophylactic antibiotic therapy, prevention of deep vein thrombosis, prevention of pulmonary embolism, etc.). Post-surgical rehabilitative therapy will be as prescribed by the investigator. Post-operative clinical evaluation will be conducted at approximately 6 weeks, 3 months, 6 months and 1 year post-operatively. Subjects will be followed post-operatively for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the surgeon will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in Microsoft Excel in a 1:1:1 ratio. The patient will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms.
| Arm | Type | Receives |
|---|---|---|
| ROSA | Active comparator | Device: ROSA Knee SystemSubjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the ROSA Knee System. |
| KneeAlign | Active comparator | Device: KneeAlign Computer Assisted Navigation SystemSubjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the KneeAlign navigation system. |
| Conventional | No intervention | –Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using conventional instrumentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is a minimum of 18 years of age
- Independent of study participation, patient is a candidate for commercially available Persona or Legion knee components implanted in accordance with product labeling
- Patient has participated in this study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee (EC) approved Informed Consent form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
Key exclusion criteria (7 listed)
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient has undergone contralateral unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA) within the last 18 months
- Hip pathology with significant bone loss (e.g., avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
- Hip pathology severely limiting range of motion (e.g., arthrodesis, severe contracture, chronic severe dislocation)
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
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 Knee SystemThe Zimmer Biomet ROSA Knee System is a commercially available, FDA approved robotic assistant for performing TKA. It uses preoperative x-rays to create a three-dimensional image of the patient's knee anatomy which is used to create a preoperative template of the implants to be used and provides intraoperative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks. | Device | ROSA |
| KneeAlign Computer Assisted Navigation SystemThe OrthAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position. | Device | KneeAlign |
Primary outcome
Implant Positioning
Time frame: Pre-Op
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Implant Positioning
Time frame: Up to 6 Hours
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Implant Positioning
Time frame: 6 weeks
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Implant Positioning
Time frame: 3 months
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Implant Positioning
Time frame: 6 months
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
Implant Positioning
Time frame: 1 year
Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.
41 secondary outcomes
Knee Questionnaire
Time frame: Pre-Op
Knee Outcome Score
Time frame: Pre-Op
Health Questionnaire
Time frame: Pre-Op
Objective Knee Assessment
Time frame: Pre-Op
Knee Alignment
Time frame: Pre-Op
Knee Instability Medial/Lateral (M/L)
Time frame: Pre-Op
Knee Instability Anterior/Posterior (A/P)
Time frame: Pre-Op
Joint Motion
Time frame: Pre-Op
Knee Questionnaire
Time frame: 6 weeks
Knee Outcome Score
Time frame: 6 weeks
Health Questionnaire
Time frame: 6 weeks
Objective Knee Assessment
Time frame: 6 weeks
Knee Alignment
Time frame: 6 weeks
Knee Instability M/L
Time frame: 6 weeks
Knee Instability A/P
Time frame: 6 weeks
Joint Motion
Time frame: 6 weeks
Patellar Tracking
Time frame: 6 weeks
Patient Satisfaction
Time frame: 6 weeks
Knee Questionnaire
Time frame: 3 months
Knee Outcome Score
Time frame: 3 months
Health Questionnaire
Time frame: 3 months
Objective Knee Assessment
Time frame: 3 months
Knee Alignment
Time frame: 3 months
Knee Instability M/L
Time frame: 3 months
Knee Instability A/P
Time frame: 3 months
Joint Motion
Time frame: 3 months
Patellar Tracking
Time frame: 3 months
Patient Satisfaction
Time frame: 3 months
Knee Questionnaire
Time frame: 6 months
Knee Outcome Score
Time frame: 6 months
Health Questionnaire
Time frame: 6 months
Knee Questionnaire
Time frame: 1 year
Knee Outcome Score
Time frame: 1 year
Health Questionnaire
Time frame: 1 year
Objective Knee Assessment
Time frame: 1 year
Knee Alignment
Time frame: 1 year
Knee Instability M/L
Time frame: 1 year
Knee Instability A/P
Time frame: 1 year
Joint Motion
Time frame: 1 year
Patellar Tracking
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee System and KneeAlign Computer Assisted Navigation System in people with Knee Osteoarthritis, run by University of California, Los Angeles at 1 site in United States.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Aug 2024. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Positioning (time frame: Pre-Op). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.