Osteoarthritis,KneeNCT01899417
Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
An observational study of Osteoarthritis,Knee, run by Restor3D at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty. This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis,Knee
- What is being tested?
- ConforMIS iTotal® Knee Replacement
- Type of treatment
- Medical device
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.
Who may be able to join
- Patient has received an iTotal or a standard total knee replacement
- Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
- >18 years of age
Who cannot join
- Participation in another clinical study that could confound results
- Patient is less than 3 months post-op
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.
This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.
Read the detailed description
STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.
STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.
- Conditions
- Osteoarthritis,Knee
- Being tested
- ConforMIS iTotal® Knee Replacement
- Keywords
- osteoarthritis, knee replacement, patient-specific, economics
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConforMIS iTotal® Knee ReplacementDevice
Also called Total knee replacement, arthoplasty, TKA, iTotal
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS iTotal® Knee Replacement | knee joint replacement Receives: Device: ConforMIS iTotal® Knee Replacement | |
| Standard Knee Replacements | knee joint replacement Receives: Device: ConforMIS iTotal® Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Measured: 1 month
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis,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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 235 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
- NCT01899417
- Sponsor's protocol ID
- 13-001
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2013
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.
PubMed 1959265Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22.
PubMed 17188876Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.
PubMed 19182028Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
PubMed 16967035
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
- Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
- ClinicalTrials.gov ID
- NCT01899417
- Acronym / sponsor ID
- 13-001
- Conditions
- Osteoarthritis,Knee
- Keywords
- osteoarthritis, knee replacement, patient-specific, economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Jul 2013 (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.
The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.
This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.
Detailed description
STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.
STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ConforMIS iTotal® Knee Replacement | – | Device: ConforMIS iTotal® Knee Replacementknee joint replacement |
| Standard Knee Replacements | – | Device: ConforMIS iTotal® Knee Replacementknee joint replacement |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.
Key inclusion criteria (3 listed)
- Patient has received an iTotal or a standard total knee replacement
- Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
- >18 years of age
Key exclusion criteria (2 listed)
- Participation in another clinical study that could confound results
- Patient is less than 3 months post-op
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 iTotal® Knee ReplacementAlso: Total knee replacement, arthoplasty, TKA, iTotalPatients that received a ConforMIS iTotal knee replacement versus other knee replacement devices. | Device | ConforMIS iTotal® Knee Replacement, Standard Knee Replacements |
Primary outcome
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Time frame: 1 month
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
Time frame: 3 months
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days 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.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 1959265Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.
- Background: PubMed 17188876Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22.
- Background: PubMed 19182028Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 16967035Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
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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,Knee, 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: 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 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?
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?
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT01899417, which also lists 6 linked publications.
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.