OsteoarthritisNCT01861028
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
An observational study of Osteoarthritis, run by Restor3D at 1 site in United States.
Trial summary
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant
Who may be able to join
- Patients who are scheduled for a standard total knee replacement
- Patient who are scheduled for patient-specific total knee replacement (iTotal)
- Patient age > 18 years
Who cannot join
- Patients who do not receive a total knee replacement
- Unwilling or unable to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Read the detailed description
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.
All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.
- Conditions
- Osteoarthritis
- Keywords
- total knee replacement, total knee arthroplasty, patient-specific
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements | |
| Phase II | The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
Measured: Intraoperatively, up to 120 minutes
Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Measured: Intraoperatively, up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2015
- Study completionDec 2015
Why it stopped: Not enough patient volume to continue the study.
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Martin, MD, Principal investigator, JFK Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861028
- Sponsor's protocol ID
- 12-002
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2013
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
- Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
- ClinicalTrials.gov ID
- NCT01861028
- Acronym / sponsor ID
- 12-002
- Conditions
- Osteoarthritis
- Keywords
- total knee replacement, total knee arthroplasty, patient-specific
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patient volume to continue the study.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Detailed description
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.
All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | –A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements |
| Phase II | – | –The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant
Key inclusion criteria (3 listed)
- Patients who are scheduled for a standard total knee replacement
- Patient who are scheduled for patient-specific total knee replacement (iTotal)
- Patient age > 18 years
Key exclusion criteria (2 listed)
- Patients who do not receive a total knee replacement
- Unwilling or unable to comply with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
Time frame: Intraoperatively, up to 120 minutes
Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
Time frame: Intraoperatively, up to 120 minutes
Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gregory Martin, MD principal investigator
JFK Medical Center
1 site in 1 country: 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 1 site 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 3 inclusion and 2 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 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 1 site 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 28 Dec 2020). 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?
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater (time frame: Intraoperatively, up to 120 minutes). 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 25 Oct 2023.