A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study

Study Overview
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Brief Summary
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The study objective is to assess patient satisfaction after the surgery with a custom-made CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty. The hypothesis is that patients receiving ORIGIN implants will experience a more natural feel of the prosthesis during the first year after the surgery compared to patients receiving VANGUARD implants (as measured with FJS), and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up. It is also supposed that the overall patient satisfaction is expected to be higher with ORIGIN PS than with VANGUARD PS treatment.

Detailed Description
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ORIGIN® PS and VANGUARD® PS are total knee prostheses, intended to be used in primary Total Knee Replacement Arthroplasty (TKA). With the ORIGIN® PS implant being customized individually made (CIM) fitting a patient's anatomy, a more natural reconstruction of knee kinematics is anticipated and ultimately a higher patient satisfaction and lower revision rate are envisioned. To date literature providing data about CIM TKA is still scarce. A study assessing kinematics after TKA found that CIM TKA more closely resembled natural knee kinematics when compared to standard off-the-shelf (OTS) TKA. This resemblance allows for a more natural femoral rollback during knee flexion, the authors found. CIM TKA demonstrates knee kinematics more similar to a normal knee studying tibiofemoral kinematics using mobile fluoroscopy in vivo. Furthermore, CIM TKA has shown to provide a more accurate tibial fit and rotation, when compared to several standard TKA. A retrospective review of 621 TKA patients, 307 with CIM TKA and 314 with conventional implants, demonstrated a decreased estimated blood loss, decreased length of stay, decreased range of motion, and no discernible difference in surgical or tourniquet time. Albeit, the differences found were not deemed clinically relevant, the study underlined the safety and efficacy of the CIM TKA technique. Patients who received CIM TKA had lower transfusion rates and fewer adverse events. Four year data from the UK National Joint Registry showed a cumulative percent revision rate of 0.5% for CIM TKA versus a cumulative percent revision rate of 1.9% for all TKA. While all this data is encouraging, randomized controlled studies and assessments of patient reported outcomes are missing. Therefore, the current study aims to close this knowledge gap and provide Level I evidence for CIM TKA by comparing the two TKA Prostheses mentioned above and to evaluate their clinical performance and safety. This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study. The study is performed in Germany, in the University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz). It is stated that 140 subjects implanted with either the ORIGIN PS or VANGUARD PS System will be included upon eligibility assessment. Subjects will be followed at one and two years after the procedure. Enrollment will occur at the time of the medical examination. It is assumed that the subjects' treatments and follow-up visits will be performed per standard of the investigational site in Germany. It is anticipated that enrollment will take approximately 18 months. As each implanted subject is to be followed for two years, the estimated study duration is approximately 48 months, excluding the time required for preparing the final report. (A loss of approximately 10% is expected at the end of the study)

Official Title
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A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: ORIGIN PS System
* Device: VANGUARD PS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent. Clinically indicated for a total Knee replacement Females who are not pregnant or lactating and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this. Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years. Exclusion Criteria: Life expectancy ≤ 1 year Age ≥ 80 years Acute or chronic, local or systemic infection Mental illness Muscular, ligamental, neurological, psychological or vascular deficits Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert) Any concomitant condition likely to affect implant integration or function Allergy or hypersensitivity to any of the materials used For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment Hip Knee Ankle (HKA) angle < 165° or > 195°

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Origine<br>Group of 70 subjects who will undergo a surgery with the ORIGIN PS System | Device: ORIGIN PS System<br>* Group of 70 subjects who will undergo a surgery with the ORIGIN PS System<br>|
| Vanguard<br>Group of 70 subjects who will undergo a surgery with the VANGUARD System | Device: VANGUARD PS System<br>* Group of 70 subjects who will undergo a surgery with the VANGUARD System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten Joint Score | The Forgotten Joint Score is a joint-specific questionnaire is defined in 12 questions and measure the ability of the patient to forget their operated knee after the surgery. The outcome Score is between 0-4. Zero is best outcome. Low score means high satisfaction. All responses are summed and multiplied by 25 (Total= 0-100) | Baseline (preoperative visit) | 
| Forgotten Joint Score | The Forgotten Joint Score is a joint-specific questionnaire is defined in 12 questions and measure the ability of the patient to forget their operated knee after the surgery. The outcome Score is between 0-4. Zero is best outcome. Low score means high satisfaction. All responses are summed and multiplied by 25 (Total= 0-100) | 1 year | 
| Forgotten Joint Score | The Forgotten Joint Score is a joint-specific questionnaire is defined in 12 questions and measure the ability of the patient to forget their operated knee after the surgery. The outcome Score is between 0-4. Zero is best outcome. Low score means high satisfaction. All responses are summed and multiplied by 25 (Total= 0-100) | 2 years | 
| The Self-Administered Patient Satisfaction Scale | The Self-Administered Patient Satisfaction Scale (SAPS) is defined in 4 questions and measure the patient satisfaction regarding the surgery with a CE marked custom-made implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device. The items include patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities. Items are scored on a 4-point Likert scale with response categories consisting of very satisfied (100 points), somewhat satisfied (75 points), somewhat dissatisfied (50 points), and very dissatisfied (25 points). The scale score is the unweighted mean of the scores from the individual items, ranging from 25 to 100 per item (with 100 being most satisfied). | Baseline (preoperative visit) | 
| The Self-Administered Patient Satisfaction Scale | The Self-Administered Patient Satisfaction Scale (SAPS) is defined in 4 questions and measure the patient satisfaction regarding the surgery with a CE marked custom-made implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device. The items include patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities. Items are scored on a 4-point Likert scale with response categories consisting of very satisfied (100 points), somewhat satisfied (75 points), somewhat dissatisfied (50 points), and very dissatisfied (25 points). The scale score is the unweighted mean of the scores from the individual items, ranging from 25 to 100 per item (with 100 being most satisfied). | 1 year | 
| The Self-Administered Patient Satisfaction Scale | The Self-Administered Patient Satisfaction Scale (SAPS) is defined in 4 questions and measure the patient satisfaction regarding the surgery with a CE marked custom-made implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device. The items include patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities. Items are scored on a 4-point Likert scale with response categories consisting of very satisfied (100 points), somewhat satisfied (75 points), somewhat dissatisfied (50 points), and very dissatisfied (25 points). The scale score is the unweighted mean of the scores from the individual items, ranging from 25 to 100 per item (with 100 being most satisfied). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score | The Knee Injury and Osteoarthritis Outcome (KOOS) Score is defined in 5 subscales (1.Pain, 2.other Symptoms, 3.Function in daily living (ADL), 4.Function in sport and recreation, and 5.knee related to Quality of life. Items are scored on 4-points Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 100 per item (with 100 indicating no symptoms and 0 indicating extreme symptoms). | Baseline (preoperative visit) | 
| Knee Injury and Osteoarthritis Outcome Score | The Knee Injury and Osteoarthritis Outcome (KOOS) Score is defined in 5 subscales (1.Pain, 2.other Symptoms, 3.Function in daily living (ADL), 4.Function in sport and recreation, and 5.knee related to Quality of life. Items are scored on 4-points Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 100 per item (with 100 indicating no symptoms and 0 indicating extreme symptoms). | 1 year | 
| Knee Injury and Osteoarthritis Outcome Score | The Knee Injury and Osteoarthritis Outcome (KOOS) Score is defined in 5 subscales (1.Pain, 2.other Symptoms, 3.Function in daily living (ADL), 4.Function in sport and recreation, and 5.knee related to Quality of life. Items are scored on 4-points Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 100 per item (with 100 indicating no symptoms and 0 indicating extreme symptoms). | 2 years | 
| Complications & revision rate | Pourcentage of complications leading to surgical revision | Baseline (surgery) | 
| Complications & revision rate | Pourcentage of complications leading to surgical revision | 1 year | 
| Complications & revision rate | Pourcentage of complications leading to surgical revision | 2 years | 
| Oxford Knee Score | The Oxford Knee Score (OKS) is 12-items questionnaire designed and developed to assess function and pain after total knee replacement surgery (arthroplasty). The Items are scored on a 4-point Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 48 (with 48 indicating best/least problems and 0 indicating worst/most severe problems). | baseline (preoperative visit) | 
| Oxford Knee Score | The Oxford Knee Score (OKS) is 12-items questionnaire designed and developed to assess function and pain after total knee replacement surgery (arthroplasty). The Items are scored on a 4-point Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 48 (with 48 indicating best/least problems and 0 indicating worst/most severe problems). | 1 year | 
| Oxford Knee Score | The Oxford Knee Score (OKS) is 12-items questionnaire designed and developed to assess function and pain after total knee replacement surgery (arthroplasty). The Items are scored on a 4-point Likert scale. The scale score is the unweighted mean of the scores, ranging from 0 to 48 (with 48 indicating best/least problems and 0 indicating worst/most severe problems). | 2 years | 
| EQ-5D-5L Score | The EQ-5D-5L Score is 5-items questionnaire designed and developed to assess the quality of life (1.mobility, 2.self care, 3.usual activities, 4.pain/discomfort, 5.anxiety/depression) The Items are scored on a 5-point Likert scale. The scale score is the weighted mean of the scores, ranging from 0 to 5 dimension (with 0 = no problems, 1 = slight problems, 2 = moderate problems, 3 = severe problems, and 4= extreme problems). | baseline (preoperative visit) | 
| EQ-5D-5L Score | The EQ-5D-5L Score is 5-items questionnaire designed and developed to assess the quality of life (1.mobility, 2.self care, 3.usual activities, 4.pain/discomfort, 5.anxiety/depression) The Items are scored on a 5-point Likert scale. The scale score is the weighted mean of the scores, ranging from 0 to 5 dimension (with 0 = no problems, 1 = slight problems, 2 = moderate problems, 3 = severe problems, and 4= extreme problems). | 1 year | 
| EQ-5D-5L Score | The EQ-5D-5L Score is 5-items questionnaire designed and developed to assess the quality of life (1.mobility, 2.self care, 3.usual activities, 4.pain/discomfort, 5.anxiety/depression) The Items are scored on a 5-point Likert scale. The scale score is the weighted mean of the scores, ranging from 0 to 5 dimension (with 0 = no problems, 1 = slight problems, 2 = moderate problems, 3 = severe problems, and 4= extreme problems). | 2 years | 
| EQ Visual Analog Scale | The EQ Visual Analog Scale (EQ VAS) records the respondent's overall current health of the patient on a vertical visual analogue scale, ranging from 0 to 100 (with 100 indicating the best health you can imagine and 0 indicating the worst health you can imagine. | Baseline (preoperative visit) | 
| EQ Visual Analog Scale | The EQ Visual Analog Scale (EQ VAS) records the respondent's overall current health of the patient on a vertical visual analogue scale, ranging from 0 to 100 (with 100 indicating the best health you can imagine and 0 indicating the worst health you can imagine. | 1 year | 
| EQ Visual Analog Scale | The EQ Visual Analog Scale (EQ VAS) records the respondent's overall current health of the patient on a vertical visual analogue scale, ranging from 0 to 100 (with 100 indicating the best health you can imagine and 0 indicating the worst health you can imagine. | 2 years | 
| Objective Knee Indicators | The Objective Knee Indicators is a knee score which assesses range of motion, stability, and alignment, ranging from 0 to 50 points (with 50 indicating a better outcome and 0 indicating a worse score. he Objective Knee Indicators is a component of The Knee Society Score (KSS), being a knee joint specific questionnaire originally developed and validated in 1989 for use in assessing the outcome of total knee replacement. | Baseline (preoperative visit) | 
| Objective Knee Indicators | The Objective Knee Indicators is a knee score which assesses range of motion, stability, and alignment, ranging from 0 to 50 points (with 50 indicating a better outcome and 0 indicating a worse score. he Objective Knee Indicators is a component of The Knee Society Score (KSS), being a knee joint specific questionnaire originally developed and validated in 1989 for use in assessing the outcome of total knee replacement. | 1 year | 
| Objective Knee Indicators | The Objective Knee Indicators is a knee score which assesses range of motion, stability, and alignment, ranging from 0 to 50 points (with 50 indicating a better outcome and 0 indicating a worse score. he Objective Knee Indicators is a component of The Knee Society Score (KSS), being a knee joint specific questionnaire originally developed and validated in 1989 for use in assessing the outcome of total knee replacement. | 2 years | 
| Single Leg Stance Test with eyes opened on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | Baseline (preoperative visit) | 
| Single Leg Stance Test with eyes closed on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | Baseline (preoperative visit) | 
| Single Leg Stance Test with eyes opened on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 1 year | 
| Single Leg Stance Test with eyes closed on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 1 year | 
| Single Leg Stance Test with eyes opened on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 2 years | 
| Single Leg Stance Test with eyes closed on the right feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 2 years | 
| Single Leg Stance Test with eyes opened on the left feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | Baseline (preoperative visit) | 
| Single Leg Stance Test with eyes closed on the left feet | The Single Leg Stance (SLS) Test measured the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | Baseline (preoperative visit) | 
| Single Leg Stance Test with eyes opened on the left feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 1 year | 
| Single Leg Stance Test with eyes closed on the left feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 1 year | 
| Single Leg Stance Test with eyes opened on the left feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 2 years | 
| Single Leg Stance Test with eyes closed on the left feet | The Single Leg Stance (SLS) Test measures the Time Ability (number of seconds) of the patient to maintain Single Leg Stance with eyes open or closed. Adults unable to balance on 1 limb for 5 secs had 2.1 times the risk of having an injurious fall than those who could balance for >5 secs. | 2 years | 
| Time Up and Go Test to assess the fall risk of the patient | The Time Up and Go (TUG) is used to assess the mobility and the fall risk of the patient. The test requires the patient to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The score is the time in second taken by the patient to complete the test (with a time higher than 13.5 seconds indicating a higher risk of fall, and a time equal or less than 13.5 seconds indicating a lower risk of fall). | Baseline (preoperative visit) | 
| Time Up and Go Test to assess the fall risk of the patient | The Time Up and Go (TUG) is used to assess the mobility and the fall risk of the patient. The test requires the patient to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The score is the time in second taken by the patient to complete the test (with a time higher than 13.5 seconds indicating a higher risk of fall, and a time equal or less than 13.5 seconds indicating a lower risk of fall). | 1 year | 
| Time Up and Go Test to assess the fall risk of the patient | The Time Up and Go (TUG) is used to assess the mobility and the fall risk of the patient. The test requires the patient to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The score is the time in second taken by the patient to complete the test (with a time higher than 13.5 seconds indicating a higher risk of fall, and a time equal or less than 13.5 seconds indicating a lower risk of fall). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORIGIN, VANGUARD, Arthroplasty, Replacement, Knee, Prosthesis