Knee Osteoarthritis, Post-traumatic Osteoarthritis
Conditions
Keywords
Primary total knee replacement
Brief summary
The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative planning imaging data. Mechanical alignment in the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared with results reported in the literature using a conventional (non-guided) approach. Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to mechanical alignment as with conventional instrumentation.
Detailed description
Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery tool. The newly developed and CE-marked X-PSI Knee System is based on long leg x-rays that are used to generate a pre-operative 3D model of the knee. The total knee replacement surgery will be planned according to this 3D model. The aim of this multi-center, prospective, non-controlled post-market study is to scientifically document the accuracy, cost-effectiveness and subsequent clinical performance of the X-PSI Knee System. The X-PSI pin guides are designed to facilitate a more simplified, efficient and customized TKA procedure compared to conventional, non-guided instrumentation. To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then be compared with current literature (70% of cases within ±3 degrees) where patients were conventionally operated with non-guided surgery. No control group will be studied. The cost-effectiveness of the X-PSI Knee System will be evaluated with an efficiency matrix to record OR set-up time, surgery time and post-processing time. Clinical outcome data of the patients will be evaluated 4-6 weeks and 1 year post-surgery with the help of patient questionnaires (VAS pain scale, EQ-5D and Oxford Knee Score), a physical exam and the assessment of radiographs. The study population will be compromised of males and females requiring total knee arthroplasty and satisfy the inclusion/exclusion criteria. The study will last one (1) year from the time of surgery. The collected data aim to improve the treatment and quality of life of patients suffering from degenerative joint diseases. In addition, shorter surgery times possibly result in reduced risk of infection, decreased time of anaesthesia and better cost-effectiveness.
Interventions
DEVICEX-PSI Knee System
Patients are operated with X-PSI Knee System guides
Sponsors
Zimmer, GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years of age or older. * Patient can follow the X-PSI Knee System imaging protocol as part of standard of care procedures. * Patient gets TKA treatment which follows the criteria of the appropriate Instruction for Use. * Patient is willing and able to cooperate in the required postoperative standard of care. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the study-related Informed Consent process and has signed the Ethics Committee approved Informed Consent
Exclusion criteria
* Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient meets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Leg Alignment | 4-6 weeks post-surgery | Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix | During surgery, immediate pre- and post-surgery processing time | The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Clinical Outcome Measure: Visual Analog Score Pain | Baseline, 4-6 weeks and 1 year post-surgery | Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10). |
| Patient Clinical Outcome Measure: Oxford Knee Score | Baseline, 4-6 weeks and 1 year post-surgery | The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome). |
| Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS) | Baseline, 4-6 weeks and 1 year post-surgery | Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement. |
| Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline, 4-6 weeks and 1 year post-surgery | The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Countries
Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Knee Arthroplasty Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 5 |
| Overall Study | The study was stopped before the patient reached the final 1 year follow-up | 1 |
Baseline characteristics
| Characteristic | Total Knee Arthroplasty | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 3 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Mechanical Leg Alignment
Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.
Time frame: 4-6 weeks post-surgery
Population: Mechanical alignment data were not collected from any participant.
Secondary
Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix
The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.
Time frame: During surgery, immediate pre- and post-surgery processing time
Population: No data on cost-effectiveness and efficiency were collected from any participant.
Other Pre-specified
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Time frame: Baseline, 4-6 weeks and 1 year post-surgery
Population: Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Mobility | 0 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Mobility | 2 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Self-Care | 1 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Usual Activities | 2 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort | 3 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Anxiety | 1 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 4- weeks post-surgery patients reprting any problem (i.e some problems/ extreme problems) : Mobility | 2 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Self-Care | 0 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems): Usual Activities | 2 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort | 3 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Anxiety | 2 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 1 year post-surgery patients reprting any problem (i.e some problems/ extreme problems) : Self-Care | 0 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 1 year post-OP patients reprting any problem (i.e some problems/ extreme problems): Usual Activities | 0 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort | 1 participants |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System | 1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Anxiety | 0 participants |
Other Pre-specified
Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)
Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: Baseline, 4-6 weeks and 1 year post-surgery
Population: Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS) | Baseline | 73.3 score on a scale | Standard Deviation 24.9 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS) | 4-6 weeks post-surgery | 63.3 score on a scale | Standard Deviation 12.5 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS) | 1 year post-surgery | 91.5 score on a scale | Standard Deviation 3.5 |
Other Pre-specified
Patient Clinical Outcome Measure: Oxford Knee Score
The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Time frame: Baseline, 4-6 weeks and 1 year post-surgery
Population: Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Oxford Knee Score | Baseline | 18.3 score on a scale | Standard Deviation 6.6 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Oxford Knee Score | 4-6 weeks post-surgery | 30.3 score on a scale | Standard Deviation 5.3 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Oxford Knee Score | 1 year post-surgery | 45.0 score on a scale | Standard Deviation 2 |
Other Pre-specified
Patient Clinical Outcome Measure: Visual Analog Score Pain
Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).
Time frame: Baseline, 4-6 weeks and 1 year post-surgery
Population: Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Visual Analog Score Pain | 4-6 weeks post-surgery | 3.7 units on a scale | Standard Deviation 2.4 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Visual Analog Score Pain | Baseline | 8.2 units on a scale | Standard Deviation 0.9 |
| Total Knee Arthroplasty | Patient Clinical Outcome Measure: Visual Analog Score Pain | 1 year post-surgery | 1.1 units on a scale | Standard Deviation 0.4 |