GonarthrosisTKA PSINCT04114201
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
A study testing PSI and Conventional in people with Gonarthrosis, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- PSI and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 3 sitesGermany
- Study dates
- 2 Aug 2012to 23 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- Informed Consent: Patient has signed a "Patient Informed Consent.
- Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- Able and willing to follow instructions and complete follow-up
- Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
Who cannot join
- Patient is skeletally immature
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- Hip or knee ankylosis
Show all 15Show fewer
- Either rheumatoid or post-traumatic knee arthritis
- Scheduled for simultaneous bilateral TKA
- Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
- Any metal within 150 mm of the joint line for the operative-side knee
- Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
- A female who is pregnant or lactating
- Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- Arterial disease or stents that would exclude the use of a tourniquet
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, 01307
Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
Lorsch, Hesse, 64653
Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
Nienburg, Lower Saxony, 31582
About this study
Official title: Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.
Read the detailed description
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.
For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.
A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
- Conditions
- Gonarthrosis
- Being tested
- PSI, Conventional
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSIProcedure or surgery
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
ConventionalProcedure or surgery
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
| Study group | Role | What they receive |
|---|---|---|
| PSI | Experimental | Patients received TKA using patient-specific Instrumentation. Receives: Procedure: PSI |
| Conventional | Active comparator | Patients received TKA conventional Instrumentation. Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
OR time
Operating Room (OR) time: incision to Close in minutes
Measured: during surgery
Secondary outcomes (6)
OR resource use: number of instrument trays
OR Efficiency measured by number of instrument trays used
Measured: during surgery
OR Setup Time
Operating Room (OR) Setup Time in minutes
Measured: during surgery
Oxford Knee Score
clinical outcome measured by the Oxford Knee Scoring System. The Oxford Knee Score is aggregated to a single score where 0 is the worst and 48 is the best Outcome.
Measured: 1 year after surgery
visual analog scale (VAS)
patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
Measured: 1 year after surgery
device alignment
device alignment as determined using radiographs (A/P long-standing and lateral films)
Measured: 1 year after surgery
EQ-5D-3L
patients' health-related Quality of life is measured by the EQ-5D-3L, which aggregates to a single index where 0 is the worst and 1 is the best outcome
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start2 Aug 2012
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients were operated consecutively with conventional and patient-specific Instrumentation.
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114201
- Sponsor's protocol ID
- TKA-PSI
- Acronym
- TKA PSI
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- 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 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
- ClinicalTrials.gov ID
- NCT04114201
- Acronym / sponsor ID
- TKA PSI / TKA-PSI
- Conditions
- Gonarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 2 Aug 2012 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.
Detailed description
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.
For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.
A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were operated consecutively with conventional and patient-specific Instrumentation.
| Arm | Type | Receives |
|---|---|---|
| PSI | Experimental | Procedure: PSIPatients received TKA using patient-specific Instrumentation. |
| Conventional | Active comparator | Procedure: ConventionalPatients received TKA conventional Instrumentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- Informed Consent: Patient has signed a "Patient Informed Consent.
- Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- Able and willing to follow instructions and complete follow-up
- Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
Key exclusion criteria (15 listed)
- Patient is skeletally immature
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
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 |
|---|---|---|
| PSIImplantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN). | Procedure or surgery | PSI |
| ConventionalImplantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN). | Procedure or surgery | Conventional |
Primary outcome
OR time
Time frame: during surgery
Operating Room (OR) time: incision to Close in minutes
6 secondary outcomes
OR resource use: number of instrument trays
Time frame: during surgery
OR Setup Time
Time frame: during surgery
Oxford Knee Score
Time frame: 1 year after surgery
visual analog scale (VAS)
Time frame: 1 year after surgery
device alignment
Time frame: 1 year after surgery
EQ-5D-3L
Time frame: 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSI and Conventional in people with Gonarthrosis, run by Technische Universität Dresden at 3 sites in Germany.
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OR time (time frame: during 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 3 Oct 2019.