Arthroplasty, Replacement, KneeScorpio NRGNCT02524730
Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study
A study testing Primary total knee replacement (Scorpio NRG CR Total Knee System) in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 5 sites in 4 countries.
Trial summary
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Primary total knee replacement (Scorpio NRG CR Total Knee System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 18 May 2009to 10 Feb 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
- The subject requires a primary total knee replacement.
- Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)
- The subject has intact collateral ligaments.
- The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- The subject is capable of understanding the patient scores in the national language.
Who cannot join
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject will be operated bilaterally.
- Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).
- Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).
- Patients who will need lower limb joint replacement for another joint within one year.
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- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion to the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).
- Female patients planning a pregnancy during the course of the study.
- The subject is a prisoner.
- severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, flexion contracture >10°
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Orthopaedische Maatschap Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
Germany1 site
Knappschaftskrankenhaus Dortmund
Dortmund, North Rhine-Westphalia, 44309
United Kingdom1 site
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
About this study
Official title: Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
Read the detailed description
Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative.
Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative.
Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Primary total knee replacement (Scorpio NRG CR Total Knee System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary total knee replacement (Scorpio NRG CR Total Knee System)Device
Scorpio NRG CR Total Knee System
| Study group | Role | What they receive |
|---|---|---|
| Scorpio NRG CR Total Knee System | Other | Primary total knee replacement Receives: Device: Primary total knee replacement (Scorpio NRG CR Total Knee System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
Assess survival (absence of revision) at 7 year follow-up
Measured: 7 year follow-up
Secondary outcomes (5)
Investigation of Clinical Performance and Patient Outcome With the 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, 3 months, 1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Measured: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Measured: Pre-operative,1, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). 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.
With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start18 May 2009
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Krismer, Prof., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524730
- Sponsor's protocol ID
- SLCRG-001-2007 / K-S-002
- Acronym
- Scorpio NRG
- 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
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
- ClinicalTrials.gov ID
- NCT02524730
- Acronym / sponsor ID
- Scorpio NRG / SLCRG-001-2007 / K-S-002
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2009 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
Detailed description
Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative.
Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative.
Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scorpio NRG CR Total Knee System | Other | Device: Primary total knee replacement (Scorpio NRG CR Total Knee System)Primary total knee replacement |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
- The subject requires a primary total knee replacement.
- Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)
- The subject has intact collateral ligaments.
Key exclusion criteria (17 listed)
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject will be operated bilaterally.
- Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).
- Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).
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 |
|---|---|---|
| Primary total knee replacement (Scorpio NRG CR Total Knee System)Scorpio NRG CR Total Knee System | Device | Scorpio NRG CR Total Knee System |
Primary outcome
Survival Rate
Time frame: 7 year follow-up
Assess survival (absence of revision) at 7 year follow-up
5 secondary outcomes
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Time frame: Pre-operative, 3 months, 1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Time frame: Pre-operative,1, 5 and optional 7 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years
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.
Martin Krismer, Prof. principal investigator
Medical University Innsbruck
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary total knee replacement (Scorpio NRG CR Total Knee System) in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 5 sites in 4 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 7 inclusion and 17 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 5 sites in Netherlands, Austria, Germany, 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 14 Jun 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?
Survival Rate (time frame: 7 year 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.