OsteoarthritisNCT01564654
A Retrospective Study of the iTotal CR Knee Replacement System
An observational study of Osteoarthritis, run by Restor3D at 4 sites in United States.
Trial summary
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- iTotal KRS
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Jan 2013
- 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 who have received an iTotal Knee replacement
Who may be able to join
- Clinical condition included in the approved Indications For Use
- Has signed the informed consent form to allow review of medical records and collection of data therein.
- > 18 years of age
Who cannot join
- Treatment with iTotal in a manner inconsistent with Instructions for Use
- Unwilling to sign then informed consent form
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Preferred Orthopedics of the Palm Beaches
Boynton Beach, Florida, 33437
STAR Orthopedics
La Quinta, California, 92253
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37203
Central Utah Clinic
Provo, Utah, 84604
About this study
Official title: A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
- Conditions
- Osteoarthritis
- Being tested
- iTotal KRS
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTotal KRSDevice
Total Knee Replacement System
| Study group | Role | What they receive |
|---|---|---|
| iTotal KRS | Not described Receives: Device: iTotal KRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function
Range of Motion
Measured: Average of 7 months post-operative
Secondary outcomes (3)
Revision Rate
Number of knees that required a reoperation to remove/replace/add implant components
Measured: Average of 7 months
Number of Transfusions
Number of knees that required a blood transfusion during the initial hospital stay post-operative
Measured: Initial hospital stay
Manipulations Under Anesthesia
Number of knees that required a subsequent procedure to restore knee range of motion
Measured: Up to 7 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564654
- Sponsor's protocol ID
- CCP 11-002
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2012
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
- ClinicalTrials.gov ID
- NCT01564654
- Acronym / sponsor ID
- CCP 11-002
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iTotal KRS | – | Device: iTotal KRS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received an iTotal Knee replacement
Key inclusion criteria (3 listed)
- Clinical condition included in the approved Indications For Use
- Has signed the informed consent form to allow review of medical records and collection of data therein.
- > 18 years of age
Key exclusion criteria (2 listed)
- Treatment with iTotal in a manner inconsistent with Instructions for Use
- Unwilling to sign then informed consent form
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 |
|---|---|---|
| iTotal KRSTotal Knee Replacement System | Device | iTotal KRS |
Primary outcome
Knee Function
Time frame: Average of 7 months post-operative
Range of Motion
3 secondary outcomes
Revision Rate
Time frame: Average of 7 months
Number of Transfusions
Time frame: Initial hospital stay
Manipulations Under Anesthesia
Time frame: Up to 7 months post-operative
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 4 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 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: 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 4 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 20 Jan 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?
Knee Function (time frame: Average of 7 months post-operative). 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; AzTrials last refreshed its copy on 6 Nov 2026.