OsteoarthritisSTEPSNCT02251522
A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
An observational study of Osteoarthritis, run by Restor3D at 16 sites in 2 countries.
Trial summary
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ConforMIS Total Knee Replacement System and Off-the-Shelf Knee Replacement System
- Type of treatment
- Medical device
- How many people
- 873 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Oct 2014to Dec 2016
- Phase
- Observational
- 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
Study population: The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.
Who may be able to join
- Implant must be at least 6 months post-op and doing well
- Patient has had a total CR knee implant
- > 18 years of age
Who cannot join
- Simultaneous bilateral procedure occurred
- BMI > 40
- Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
- Participation in another clinical study which would confound results
- Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States12 sites
Great Lakes Bone & Joint Center
Battle Creek, Michigan, 49015
Bethesda Orthopedic
Bethesda, Maryland, 20817
Advanced Orthopedics & Sports Medicine
Cypress, Texas, 77429
Institute for Orthopaedic Surgery & Sports Medicine
Fort Myers, Florida, 33919
Orthopaedic Institute of Henderson
Henderson, Nevada, 89052
Baptist Health South Florida
Miami, Florida, 33176
Denver-Vail Orthopedics
Parker, Colorado, 80134
Coastal Orthopaedic & Sports Medicine Ctr
Port Saint Lucie, Florida, 34996
St. Lawrence Health System
Potsdam, New York, 13676
Orthopedic Specialties of Spartanburg
Spartanburg, South Carolina, 29303
Lederman-Kwartowitz Center for Orthopedics and Sports Medicine
West Bloomfield, Michigan, 48323
Excel Orthopaedic Specialists
Woburn, Massachusetts, 01801
Germany4 sites
Vitos Orthopädische Klinik Kassel
Kassel
MedArtes
Neutraubling
Elblandkliniken Stiftung
Radebeul
Sportklinik Stuttgart
Stuttgart
About this study
Official title: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
Read the detailed description
The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities that the patients are familiar with.
- Conditions
- Osteoarthritis
- Being tested
- ConforMIS Total Knee Replacement System, Off-the-Shelf Knee Replacement System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConforMIS Total Knee Replacement SystemDevice
Total knee replacement system using a patient specific implant.
Off-the-Shelf Knee Replacement SystemDevice
Total knee replacement system not using a patient specific implant.
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS iTotal Knee Replacement System | Patients who have had an iTotal knee replacement at least 6 months prior to testing Receives: Device: ConforMIS Total Knee Replacement System | |
| Off-the-Shelf Knee Replacement System | Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing Receives: Device: Off-the-Shelf Knee Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome time differences between the two groups
The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
Measured: at least 6 months post-op
Secondary outcomes (3)
Outcomes questionnaire- Knee Society Score
Comparing different patient outcome scores between the two groups
Measured: At least 6 months post op
Outcomes questionnaire- KOOS
Comparing different patient outcome scores between the two groups
Measured: At least 6 months post op
Outcomes questionnaire- Forgotten Joint Score
Comparing different patient outcome scores between the two groups
Measured: At least 6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Tait, MD, Principal investigator, Orthopaedic Institute of HendersonMary O'Connor, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251522
- Sponsor's protocol ID
- 14-001
- Acronym
- STEPS
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2014
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
- ClinicalTrials.gov ID
- NCT02251522
- Acronym / sponsor ID
- STEPS / 14-001
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Sep 2014 (estimated)
- 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.
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
Detailed description
The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities that the patients are familiar with.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ConforMIS iTotal Knee Replacement System | – | Device: ConforMIS Total Knee Replacement SystemPatients who have had an iTotal knee replacement at least 6 months prior to testing |
| Off-the-Shelf Knee Replacement System | – | Device: Off-the-Shelf Knee Replacement SystemPatients who have had an off-the-shelf knee replacement at least 6 months prior to testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.
Key inclusion criteria (3 listed)
- Implant must be at least 6 months post-op and doing well
- Patient has had a total CR knee implant
- > 18 years of age
Key exclusion criteria (5 listed)
- Simultaneous bilateral procedure occurred
- BMI > 40
- Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
- Participation in another clinical study which would confound results
- Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
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 |
|---|---|---|
| ConforMIS Total Knee Replacement SystemTotal knee replacement system using a patient specific implant. | Device | ConforMIS iTotal Knee Replacement System |
| Off-the-Shelf Knee Replacement SystemTotal knee replacement system not using a patient specific implant. | Device | Off-the-Shelf Knee Replacement System |
Primary outcome
Functional Outcome time differences between the two groups
Time frame: at least 6 months post-op
The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
3 secondary outcomes
Outcomes questionnaire- Knee Society Score
Time frame: At least 6 months post op
Outcomes questionnaire- KOOS
Time frame: At least 6 months post op
Outcomes questionnaire- Forgotten Joint Score
Time frame: At least 6 months post op
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 25 Oct 2023.
- 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.
Robert Tait, MD principal investigator
Orthopaedic Institute of Henderson
Mary O'Connor, MD study chair
Yale University
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Restor3D at 16 sites in 2 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 3 inclusion and 5 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, 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?
Functional Outcome time differences between the two groups (time frame: at least 6 months post-op). 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 25 Oct 2023.