Knee OsteoarthritisX-PSINCT03275246
Establish Implant Accuracy With X-PSI Knee System
A study testing X-PSI Knee System in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by Zimmer, GmbH at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- What is being tested?
- X-PSI Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 5 Oct 2018to 17 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient meets exclusion criteria of the appropriate Instruction for Use
- Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required from them
- Patient is known to be pregnant
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
HELIOS Kliniken Mittelweser GmbH
Nienburg, 31582
Knie Praxis Prof. Dr. Tibesku
Straubing, 94315
About this study
Official title: Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- Being tested
- X-PSI Knee System
- Keywords
- Primary total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-PSI Knee SystemDevice
Patients are operated with X-PSI Knee System guides
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Experimental | Patients undergoing total knee arthroplasty Receives: Device: X-PSI Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks post-surgery
Secondary outcomes (1)
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.
Measured: During surgery, immediate pre- and post-surgery processing time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start5 Oct 2018
- Primary completion20 Dec 2019
- Study completion17 Nov 2020
Why it stopped: The clinical study was stopped due to very low enrolment numbers. Due to the very slow enrolment, the goal of the study cannot be reached within a reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Schaetti, PhD, Study chair, Jr. Clinical Project Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275246
- Sponsor's protocol ID
- CSE2017-01K
- Acronym
- X-PSI
- Status last verified
- Sep 2021
- First submitted
- 24 Aug 2017
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study
- ClinicalTrials.gov ID
- NCT03275246
- Acronym / sponsor ID
- X-PSI / CSE2017-01K
- Conditions
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- Keywords
- Primary total knee replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study was stopped due to very low enrolment numbers. Due to the very slow enrolment, the goal of the study cannot be reached within a reasonable time frame.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zimmer, GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | Experimental | Device: X-PSI Knee SystemPatients undergoing total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient meets exclusion criteria of the appropriate Instruction for Use
- Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required from them
- Patient is known to be pregnant
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 |
|---|---|---|
| X-PSI Knee SystemPatients are operated with X-PSI Knee System guides | Device | Total knee arthroplasty |
Primary outcome
Mechanical Leg Alignment
Time frame: 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.
1 secondary outcome
Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix
Time frame: During surgery, immediate pre- and post-surgery processing time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Oliver Schaetti, PhD study chair
Jr. Clinical Project Lead
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-PSI Knee System in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by Zimmer, GmbH at 4 sites in 3 countries.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mechanical Leg Alignment (time frame: 4-6 weeks post-surgery). 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 6 Oct 2021.