Arthroplasty, Replacement, KneeScorpioNRGPSNCT02520531
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
A study testing Scorpio PS (posterior stable) and Scorpio NRG PS in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Netherlands.
Trial summary
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Scorpio PS (posterior stable) and Scorpio NRG PS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to 28 Jun 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring a primary total knee arthroplasty (TKA)
- Male and nonpregnant female patients
- Between 18 and 80 years of age at time of surgery
- Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
- No previous osteosynthesis of the involved knee during the last 12 months
- Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
- Patients who are capable of, and have given, informed consent for participation in the study
Who cannot join
- Patients requiring revision surgery of a previous implanted total knee system
- Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
- Patients with active infection
- Patients with malignancy
- Patients with an immobile hip or ankle arthrodesis
- Severe obese patients (BMI > 35)
Show all 9Show fewer
- Patients with a neurological deficit
- Previous history of unicompartmental knee arthroplasty or patellar prosthesis
- Patients with concurrent illnesses which are likely to affect their outcome
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Central Trial Center Maastricht BV
Maastricht, Limburg, 6229 HX
About this study
Official title: Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
Read the detailed description
Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.
Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.
Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Scorpio PS (posterior stable), Scorpio NRG PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scorpio PS (posterior stable)Device
Implantation of total knee prosthesis
Scorpio NRG PSDevice
Implantation of total knee prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Scorpio PS | Active comparator | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Receives: Device: Scorpio PS (posterior stable) |
| Scorpio NRG PS | Active comparator | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Receives: Device: Scorpio NRG PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Maximum Passive and Active Flexion.
Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis.
The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.
Measured: 5 years follow-up
Secondary outcomes (4)
Knee Society Score (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Measured: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Chair Raise Test
A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms.
Measured: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
WOMAC Patient Questionnaire
The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes.
Measured: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire
The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.
Measured: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2010
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
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 Arthroplasty, Replacement, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Feczko, MD, Principal investigator, Clinical Trial Center Maastricht BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520531
- Sponsor's protocol ID
- 20100506 /K-S-006
- Acronym
- ScorpioNRGPS
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2015
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
- ClinicalTrials.gov ID
- NCT02520531
- Acronym / sponsor ID
- ScorpioNRGPS / 20100506 /K-S-006
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
Detailed description
Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.
Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.
Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scorpio PS | Active comparator | Device: Scorpio PS (posterior stable)Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. |
| Scorpio NRG PS | Active comparator | Device: Scorpio NRG PSPatients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients requiring a primary total knee arthroplasty (TKA)
- Male and nonpregnant female patients
- Between 18 and 80 years of age at time of surgery
- Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
- No previous osteosynthesis of the involved knee during the last 12 months
Key exclusion criteria (9 listed)
- Patients requiring revision surgery of a previous implanted total knee system
- Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
- Patients with active infection
- Patients with malignancy
- Patients with an immobile hip or ankle arthrodesis
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 |
|---|---|---|
| Scorpio PS (posterior stable)Implantation of total knee prosthesis | Device | Scorpio PS |
| Scorpio NRG PSImplantation of total knee prosthesis | Device | Scorpio NRG PS |
Primary outcome
Comparison of Maximum Passive and Active Flexion.
Time frame: 5 years follow-up
Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.
4 secondary outcomes
Knee Society Score (KSS)
Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Chair Raise Test
Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
WOMAC Patient Questionnaire
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Feczko, MD principal investigator
Clinical Trial Center Maastricht BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scorpio PS (posterior stable) and Scorpio NRG PS in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Netherlands.
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 7 inclusion and 9 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 20 Sep 2019). 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?
Comparison of Maximum Passive and Active Flexion. (time frame: 5 years follow-up). 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 22 Feb 2024.