Osteo Arthritis KneeNCT03289000
A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
An observational study of Osteo Arthritis Knee, run by Restor3D at 2 sites in United States.
Trial summary
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- iTotal Posterior Stabilized (PS) Knee Replacement System
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2017to 31 Dec 2017
- 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: Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.
Who may be able to join
- Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
- Over 18 Years of age
Who cannot join
- 1. BMI > 40
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Scott Orthopedic Center
Huntington, West Virginia, 25702
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37203
About this study
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.
Read the detailed description
Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.
- Demographics and Medical History
- Pre \& Post-Operative Data including Range of Motion
- Surgical Data
- Survivorship (phone/email or last known visit)
- Patient Reported Outcomes (phone/email single time point visit)
- Patient Satisfaction
- KOOS Jr.
- Conditions
- Osteo Arthritis Knee
- Being tested
- iTotal Posterior Stabilized (PS) Knee Replacement System
- Keywords
- osteoarthritis, knee arthroplasty, knee replacement, 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.
iTotal Posterior Stabilized (PS) Knee Replacement SystemDevice
Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS PS Group | Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System Receives: Device: iTotal Posterior Stabilized (PS) Knee Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and Medical History
Demographics and medical history gathered from medical records
Measured: 1 year
Pre and Post Operative Range of Motion
Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start24 Apr 2017
- Primary completion4 Aug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289000
- Sponsor's protocol ID
- 16-004
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2017
- Last updated
- 25 Oct 2023
- Results posted
- No
- 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
- ClinicalTrials.gov ID
- NCT03289000
- Acronym / sponsor ID
- 16-004
- Conditions
- Osteo Arthritis Knee
- Keywords
- osteoarthritis, knee arthroplasty, knee replacement, patient specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Sep 2017 (actual)
- 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.
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.
Detailed description
Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.
- Demographics and Medical History
- Pre \& Post-Operative Data including Range of Motion
- Surgical Data
- Survivorship (phone/email or last known visit)
- Patient Reported Outcomes (phone/email single time point visit)
- Patient Satisfaction
- KOOS Jr.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ConforMIS PS Group | – | Device: iTotal Posterior Stabilized (PS) Knee Replacement SystemPatients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.
Key inclusion criteria (2 listed)
- Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
- Over 18 Years of age
Key exclusion criteria (1 listed)
- 1. BMI > 40
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 Posterior Stabilized (PS) Knee Replacement SystemPatient-specific posterior stabilized total knee replacement and patient specific surgical jigs | Device | ConforMIS PS Group |
Primary outcome
Demographics and Medical History
Time frame: 1 year
Demographics and medical history gathered from medical records
Pre and Post Operative Range of Motion
Time frame: 1 year
Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee, run by Restor3D at 2 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 2 inclusion and 1 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 2 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?
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?
Demographics and Medical History (time frame: 1 year). 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.