Arthropathy of KneeNCT00965146
Scorpio® Cruciate Retaining (CR) Outcomes Study
A study testing Scorpio® CR Total Knee System in people with Arthropathy of Knee, run by Stryker Orthopaedics at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- Scorpio® CR Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2001to 23 Jul 2009
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is a male or non-pregnant female between the ages of 21-80.
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the IRB approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient has inflammatory arthritis.
- The subject is morbidly obese, >60% over ideal body weight for frame and height.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- Patient 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.
Show all 12Show fewer
- The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements.
- The subject's bone stock is 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.
- The subject is a prisoner.
- The subject is pregnant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dearborn Orthopaedics
Dearborn, Michigan, 48124
Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, 46237
Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, 72205
Jewish Physician Group
Louisville, Kentucky, 40202
Beth Israel Medical Center
New York, New York, 10021
About this study
Official title: An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System
The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
Read the detailed description
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use.
The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.
Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.
The objectives of this study are to:
- Evaluate the effect of system component design on functional performance.
- Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
- Evaluate complications and the rates in which they occur.
- Conditions
- Arthropathy of Knee
- Being tested
- Scorpio® CR Total Knee System
- Keywords
- Osteoarthritis, traumatic arthritis, avascular necrosis
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scorpio® CR Total Knee SystemDevice
Also called Scorpio® Cruciate Retaining (CR) Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
| Study group | Role | What they receive |
|---|---|---|
| Scorpio® CR Total Knee System | Experimental | Scorpio® CR Total Knee System Study Device Receives: Device: Scorpio® CR Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Measured: 15 years
Evaluate Complication Rate.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJun 2001
- Primary completion23 Jul 2009
Why it stopped: Terminated due to lagging follow-up.
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 Arthropathy of 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C. Lowry Barnes, MD, Study chair, Foundation for Musculoskeletal Research and EducationLawrence Morawa, MD, Principal investigator, Dearborn OrthopaedicsArthur Malkani, MD, Principal investigator, Jewish Physician GroupFrank Kolisek, MD, Principal investigator, Orthopaedic Research Foundation, Inc.Steven Harwin, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965146
- Sponsor's protocol ID
- 48
- Status last verified
- Apr 2013
- First submitted
- 11 Aug 2009
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System
- ClinicalTrials.gov ID
- NCT00965146
- Acronym / sponsor ID
- 48
- Conditions
- Arthropathy of Knee
- Keywords
- Osteoarthritis, traumatic arthritis, avascular necrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lagging follow-up.
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- 23 Jul 2009 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 15 Feb 2013
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 evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
Detailed description
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use.
The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.
Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.
The objectives of this study are to:
- Evaluate the effect of system component design on functional performance.
- Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
- Evaluate complications and the rates in which they occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scorpio® CR Total Knee System | Experimental | Device: Scorpio® CR Total Knee SystemScorpio® CR Total Knee System Study Device |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is a male or non-pregnant female between the ages of 21-80.
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the IRB approved, study specific Informed Patient Consent Form.
Key exclusion criteria (12 listed)
- Patient has inflammatory arthritis.
- The subject is morbidly obese, >60% over ideal body weight for frame and height.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- Patient 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.
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® CR Total Knee SystemAlso: Scorpio® Cruciate Retaining (CR) Total Knee SystemAll subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. | Device | Scorpio® CR Total Knee System |
Primary outcome
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
Time frame: 15 years
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Evaluate Complication Rate.
Time frame: 15 years
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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.
C. Lowry Barnes, MD study chair
Foundation for Musculoskeletal Research and Education
Lawrence Morawa, MD principal investigator
Dearborn Orthopaedics
Arthur Malkani, MD principal investigator
Jewish Physician Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scorpio® CR Total Knee System in people with Arthropathy of Knee, run by Stryker Orthopaedics at 5 sites in United States.
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 12 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 17 Nov 2017. 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 United States. 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 15 Feb 2013). 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?
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings. (time frame: 15 years). The study lists 2 primary outcomes in all. 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 17 Nov 2017.