Osteoarthritis, Knee
Conditions
Keywords
Knee arthroplasty, Knee function, Total knee replacement, Persona total knee system, NexGen total knee system
Brief summary
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
Detailed description
Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated. The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability. The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System. This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.
Interventions
DEVICEPersona total knee system
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
DEVICENexgen total knee system
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement * \>18 years of age * Participants must be able to speak and understand Danish * Participants must be able to give informed consent and be cognitively intact * Participants must be able to complete all post-operative controls * Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3 * Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability)
Exclusion criteria
* Terminal illness * Revision knee replacement surgery * Rheumatoid Arthritis (RA) * Traumatic etiology * Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. * Altered pain perception and / or neurologic affection due to diabetes or other disorders. * Patients will be excluded intraoperative if CR implant is not suitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | 3 months, 1 year and 2 years postoperatively | The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 3 months, 1 year and 2 years postoperatively | The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score). |
| Forgotten Joint Score (FJS) | 3 months, 1 year and 2 years postoperatively | The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of the joint during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of joint awareness, while a total score of 0 indicates the highest level of joint awareness. |
| Patient Satisfaction and Anchoring Questions - Question 1 | 3 months, 1 year and 2 years postoperatively | Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?" |
| Patient Satisfaction and Anchoring Questions - Question 2 | 3 months, 1 year and 2 years postoperatively | Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?" |
| Patient Satisfaction and Anchoring Questions - Question 3 | 3 months, 1 year and 2 years postoperatively | Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?" |
| Patient Satisfaction and Anchoring Questions - Question 4 | 3 months, 1 year and 2 years postoperatively | Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?" |
| EuroQol 5D (EQ-5D) Score | 3 months, 1 year and 2 years postoperatively | The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead. |
| Radiolucency / Osteolysis | Immediate postoperative and 3 months, 1 year and 2 years postoperatively | All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately. |
| Long-term Survivorship | 5, 7 and 10 years postoperatively. | Registry data at 5, 7 and 10 years postoperatively. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORAnders Troelsen, Professor
Hvidovre University Hospital
Participant flow
Pre-assignment details
18 patients not assigned to any group: 5 rescinded consent before surgery, 13 recorded as lost to follow-up for other reasons
Participants by arm
| Arm | Count |
|---|---|
| Persona CR Patients who received a Persona CR total knee implant | 156 |
| NexGen CR Patients who received a NexGen CR total knee implant | 155 |
| Total | 311 |
Baseline characteristics
| Characteristic | NexGen CR | Total | Persona CR |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 9 | 67.9 years STANDARD_DEVIATION 8.6 | 68.1 years STANDARD_DEVIATION 8.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Denmark | 155 participants | 311 participants | 156 participants |
| Sex: Female, Male Female | 90 Participants | 189 Participants | 99 Participants |
| Sex: Female, Male Male | 65 Participants | 122 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 156 | 0 / 155 |
| other Total, other adverse events | 16 / 156 | 20 / 155 |
| serious Total, serious adverse events | 23 / 156 | 28 / 155 |
Outcome results
Primary
Oxford Knee Score
The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Persona CR | Oxford Knee Score | Preoperative | 22.1 score on a scale | Standard Deviation 6.7 |
| Persona CR | Oxford Knee Score | 3 months | 33.5 score on a scale | Standard Deviation 7.8 |
| Persona CR | Oxford Knee Score | 1 year | 39.5 score on a scale | Standard Deviation 7.7 |
| Persona CR | Oxford Knee Score | 2 years | 40.7 score on a scale | Standard Deviation 7.3 |
| NexGen CR | Oxford Knee Score | 2 years | 40.8 score on a scale | Standard Deviation 6.6 |
| NexGen CR | Oxford Knee Score | Preoperative | 22.2 score on a scale | Standard Deviation 6.5 |
| NexGen CR | Oxford Knee Score | 1 year | 38.6 score on a scale | Standard Deviation 7.6 |
| NexGen CR | Oxford Knee Score | 3 months | 32.9 score on a scale | Standard Deviation 7.9 |
p-value: <0.05t-test, 1 sided
Secondary
EuroQol 5D (EQ-5D) Score
The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead.
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Persona CR | EuroQol 5D (EQ-5D) Score | Preoperative | 0.500 score on a scale | Standard Deviation 0.272 |
| Persona CR | EuroQol 5D (EQ-5D) Score | 3 months | 0.765 score on a scale | Standard Deviation 0.19 |
| Persona CR | EuroQol 5D (EQ-5D) Score | 2 years | 0.868 score on a scale | Standard Deviation 0.187 |
| Persona CR | EuroQol 5D (EQ-5D) Score | 1 year | 0.840 score on a scale | Standard Deviation 0.201 |
| NexGen CR | EuroQol 5D (EQ-5D) Score | 2 years | 0.866 score on a scale | Standard Deviation 0.197 |
| NexGen CR | EuroQol 5D (EQ-5D) Score | Preoperative | 0.516 score on a scale | Standard Deviation 0.272 |
| NexGen CR | EuroQol 5D (EQ-5D) Score | 3 months | 0.778 score on a scale | Standard Deviation 0.173 |
| NexGen CR | EuroQol 5D (EQ-5D) Score | 1 year | 0.840 score on a scale | Standard Deviation 0.173 |
Secondary
Forgotten Joint Score (FJS)
The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of the joint during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of joint awareness, while a total score of 0 indicates the highest level of joint awareness.
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Persona CR | Forgotten Joint Score (FJS) | Preoperative | 14.3 score on a scale | Standard Error 13.7 |
| Persona CR | Forgotten Joint Score (FJS) | 3 months | 42.8 score on a scale | Standard Error 27.8 |
| Persona CR | Forgotten Joint Score (FJS) | 1 year | 60.3 score on a scale | Standard Error 27.8 |
| Persona CR | Forgotten Joint Score (FJS) | 2 years | 65.0 score on a scale | Standard Error 29 |
| NexGen CR | Forgotten Joint Score (FJS) | 2 years | 64.3 score on a scale | Standard Error 27 |
| NexGen CR | Forgotten Joint Score (FJS) | Preoperative | 14.1 score on a scale | Standard Error 13.4 |
| NexGen CR | Forgotten Joint Score (FJS) | 1 year | 56.2 score on a scale | Standard Error 29.2 |
| NexGen CR | Forgotten Joint Score (FJS) | 3 months | 42.6 score on a scale | Standard Error 26 |
Secondary
Long-term Survivorship
Registry data at 5, 7 and 10 years postoperatively.
Time frame: 5, 7 and 10 years postoperatively.
Secondary
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score).
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Persona CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 3 months | 50.0 score on a scale | Standard Deviation 30.8 |
| Persona CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | Preoperative | 16.4 score on a scale | Standard Deviation 19.7 |
| Persona CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 2 years | 70.5 score on a scale | Standard Deviation 31.2 |
| Persona CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 1 year | 71.4 score on a scale | Standard Deviation 30.4 |
| NexGen CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 2 years | 69.4 score on a scale | Standard Deviation 31 |
| NexGen CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | Preoperative | 15.2 score on a scale | Standard Deviation 19.4 |
| NexGen CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 1 year | 64.3 score on a scale | Standard Deviation 31.9 |
| NexGen CR | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | 3 months | 49.3 score on a scale | Standard Deviation 30.5 |
Secondary
Patient Satisfaction and Anchoring Questions - Question 1
Patients were asked to answer the following satisfaction/anchoring question: How are your knee problems now, compared to prior to your operation?
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change, not enough to be an important worsening | 2 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change, not enough to be an important worsening | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Better, an important improvement | 109 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Somewhat better, but enough to be an important improvement | 31 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change, not enough to be an important improvement | 6 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | About the same | 3 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Somewhat worse, but enough to be an important worsening | 2 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Worse, an important worsening | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Better, an important improvement + About the same | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change,not enough to be an important worsening + Somewhat worse | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Better, an important improvement | 123 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Somewhat better, but enough to be an important improvement | 16 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change, not enough to be an important improvement | 6 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | About the same | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change, not enough to be an important worsening | 2 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Somewhat worse, but enough to be an important worsening | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Worse, an important worsening | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Better, an important improvement + About the same | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change,not enough to be an important worsening + Somewhat worse | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Better, an important improvement | 118 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Somewhat better, but enough to be an important improvement | 18 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change, not enough to be an important improvement | 3 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | About the same | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Somewhat worse, but enough to be an important worsening | 1 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Worse, an important worsening | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Better, an important improvement + About the same | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change,not enough to be an important worsening + Somewhat worse | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Better, an important improvement | 123 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | About the same | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | About the same | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change, not enough to be an important worsening | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Somewhat worse, but enough to be an important worsening | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Better, an important improvement | 99 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change, not enough to be an important worsening | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Somewhat better, but enough to be an important improvement | 33 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Somewhat better, but enough to be an important improvement | 19 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change, not enough to be an important improvement | 7 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Somewhat worse, but enough to be an important worsening | 5 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | About the same | 4 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Worse, an important worsening | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change, not enough to be an important worsening | 4 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Better, an important improvement + About the same | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Somewhat worse, but enough to be an important worsening | 3 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Worse, an important worsening | 3 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change, not enough to be an important improvement | 2 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Better, an important improvement + About the same | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Better, an important improvement + About the same | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 3 months | Very small change,not enough to be an important worsening + Somewhat worse | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Worse, an important worsening | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Better, an important improvement | 111 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change,not enough to be an important worsening + Somewhat worse | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Somewhat better, but enough to be an important improvement | 29 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 2 years | Very small change,not enough to be an important worsening + Somewhat worse | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 1 | 1 year | Very small change, not enough to be an important improvement | 2 Participants |
Secondary
Patient Satisfaction and Anchoring Questions - Question 2
Patients were asked to answer the following satisfaction/anchoring question: Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 3 months | Yes | 122 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 3 months | No | 32 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 1 year | Yes | 127 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 1 year | No | 22 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 2 years | Yes | 130 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 2 | 2 years | No | 12 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 2 years | Yes | 137 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 3 months | Yes | 119 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 1 year | No | 19 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 3 months | No | 32 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 2 years | No | 10 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 2 | 1 year | Yes | 132 Participants |
Secondary
Patient Satisfaction and Anchoring Questions - Question 3
Patients were asked to answer the following satisfaction/anchoring question: If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | No answer provided | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | No answer provided | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | No | 27 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | Yes | 4 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | Yes | 4 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | No | 8 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | Yes | 5 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | No answer provided | 0 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | No | 18 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | No answer provided | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | Yes | 1 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | No | 29 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 3 months | No answer provided | 2 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | Yes | 8 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | No | 11 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 1 year | No answer provided | 0 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | Yes | 4 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 3 | 2 years | No | 5 Participants |
Secondary
Patient Satisfaction and Anchoring Questions - Question 4
Patients were asked to answer the following satisfaction/anchoring question: Would you have your knee operated again?
Time frame: 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | Yes, definitely | 112 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | Maybe, don't know | 25 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | Maybe, don't know | 32 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | No | 10 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | Yes, definitely | 121 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | No | 3 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | Yes, definitely | 114 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | Maybe, don't know | 22 Participants |
| Persona CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | No | 6 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | Yes, definitely | 114 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | Yes, definitely | 119 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | No | 10 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | Maybe, don't know | 25 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | Yes, definitely | 116 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 1 year | No | 7 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | Maybe, don't know | 27 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 2 years | Maybe, don't know | 23 Participants |
| NexGen CR | Patient Satisfaction and Anchoring Questions - Question 4 | 3 months | No | 8 Participants |
Secondary
Radiolucency / Osteolysis
All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately.
Time frame: Immediate postoperative and 3 months, 1 year and 2 years postoperatively
Population: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Persona CR | Radiolucency / Osteolysis | Immediate postoperative : Tibial lucency | 0 Participants |
| Persona CR | Radiolucency / Osteolysis | 3 months : Femoral lucency | 7 Participants |
| Persona CR | Radiolucency / Osteolysis | Immediate postoperative : Femoral lucency | 1 Participants |
| Persona CR | Radiolucency / Osteolysis | 3 months : Tibial lucency | 3 Participants |
| Persona CR | Radiolucency / Osteolysis | 1 year : Tibial lucency | 6 Participants |
| Persona CR | Radiolucency / Osteolysis | 1 year : Femoral lucency | 14 Participants |
| Persona CR | Radiolucency / Osteolysis | 2 years : Tibial lucency | 14 Participants |
| Persona CR | Radiolucency / Osteolysis | 2 years : Femoral lucency | 21 Participants |
| NexGen CR | Radiolucency / Osteolysis | 2 years : Femoral lucency | 20 Participants |
| NexGen CR | Radiolucency / Osteolysis | 1 year : Tibial lucency | 16 Participants |
| NexGen CR | Radiolucency / Osteolysis | Immediate postoperative : Tibial lucency | 0 Participants |
| NexGen CR | Radiolucency / Osteolysis | 2 years : Tibial lucency | 16 Participants |
| NexGen CR | Radiolucency / Osteolysis | Immediate postoperative : Femoral lucency | 2 Participants |
| NexGen CR | Radiolucency / Osteolysis | 1 year : Femoral lucency | 22 Participants |
| NexGen CR | Radiolucency / Osteolysis | 3 months : Tibial lucency | 9 Participants |
| NexGen CR | Radiolucency / Osteolysis | 3 months : Femoral lucency | 9 Participants |