Trial Outcomes & Findings for Establish Implant Accuracy With X-PSI Knee System (NCT NCT03275246)
NCT ID: NCT03275246
Last Updated: 2021-10-06
Results Overview
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.
TERMINATED
NA
8 participants
4-6 weeks post-surgery
2021-10-06
Participant Flow
Participant milestones
| Measure |
Total Knee Arthroplasty
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Total Knee Arthroplasty
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
The study was stopped before the patient reached the final 1 year follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Knee Arthroplasty
n=3 Participants
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks post-surgeryPopulation: Mechanical alignment data were not collected from any participant.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During surgery, immediate pre- and post-surgery processing timePopulation: No data on cost-effectiveness and efficiency were collected from any participant.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4-6 weeks and 1 year post-surgeryPopulation: 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)
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).
Outcome measures
| Measure |
Total Knee Arthroplasty
n=3 Participants
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Patient Clinical Outcome Measure: Visual Analog Score Pain
Baseline
|
8.2 units on a scale
Standard Deviation 0.9
|
|
Patient Clinical Outcome Measure: Visual Analog Score Pain
4-6 weeks post-surgery
|
3.7 units on a scale
Standard Deviation 2.4
|
|
Patient Clinical Outcome Measure: Visual Analog Score Pain
1 year post-surgery
|
1.1 units on a scale
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4-6 weeks and 1 year post-surgeryPopulation: 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)
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).
Outcome measures
| Measure |
Total Knee Arthroplasty
n=3 Participants
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Patient Clinical Outcome Measure: Oxford Knee Score
1 year post-surgery
|
45.0 score on a scale
Standard Deviation 2.0
|
|
Patient Clinical Outcome Measure: Oxford Knee Score
Baseline
|
18.3 score on a scale
Standard Deviation 6.6
|
|
Patient Clinical Outcome Measure: Oxford Knee Score
4-6 weeks post-surgery
|
30.3 score on a scale
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4-6 weeks and 1 year post-surgeryPopulation: 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)
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.
Outcome measures
| Measure |
Total Knee Arthroplasty
n=3 Participants
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)
Baseline
|
73.3 score on a scale
Standard Deviation 24.9
|
|
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
|
|
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 outcome
Timeframe: Baseline, 4-6 weeks and 1 year post-surgeryPopulation: 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)
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.
Outcome measures
| Measure |
Total Knee Arthroplasty
n=3 Participants
Patients undergoing total knee arthroplasty
X-PSI Knee System: Patients are operated with X-PSI Knee System guides
|
|---|---|
|
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Mobility
|
2 participants
|
|
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Self-Care
|
1 participants
|
|
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Usual Activities
|
2 participants
|
|
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort
|
3 participants
|
|
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Anxiety
|
1 participants
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Total Knee Arthroplasty
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60