AzTrials
AzTrials

Osteoarthritis, KneeNCT03146819

A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

An observational study of Osteoarthritis, Knee, run by Restor3D at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
iTotal PS Knee Replacement System and Off-the-Shelf Knee Replacement System
Type of treatment
Medical device
How many people
31 participants
Where
1 siteUnited States
Study dates
16 Dec 2016to 31 May 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: 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 a minimum of 6 months post-op and doing well in the opinion of site staff
  • Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
  • > 18 years of age
  • Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations

Who cannot join

  • Simultaneous or staged bilateral procedure
  • 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

1 site in 1 country.

United States1 site

  • Bethesda Orthopedic

    Bethesda, Maryland, 20817

Other trials in United States

About this study

Official title: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Read the detailed description

This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).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 with which the subjects are familiar.

Being tested
iTotal PS Knee Replacement System, Off-the-Shelf Knee Replacement System
Keywords
osteoarthritis, osteoarthritis knee, total knee replacement, patient specific, total knee arthroplasty, orthopedics
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.

  • iTotal PS Knee Replacement SystemDevice

    Total Knee Replacement systems (Patient Specific)

  • Off-the-Shelf Knee Replacement SystemDevice

    Total Knee Replacement systems (Off-the-shelf)

Study groups in NCT03146819
Study groupRoleWhat they receive
iTotal PS KRSPatients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing.
Receives: Device: iTotal PS Knee Replacement System
Off-the-Shelf KRSPatients who have had an off-the-shelf (posterior stabilized) 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.

  1. Functional testing differences

    Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants

    Measured: At least 6 months post-surgery

Secondary outcomes (2)

  1. Knee Society Clinical Rating Score

    Comparison of scores and sub-scores from the following questionnaires between the study arms

    Measured: At least 6 months post-surgery

  2. The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Comparison of scores and sub-scores from the following questionnaires between the study arms

    Measured: At least 6 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study start16 Dec 2016
  3. Primary completion31 May 2017
  4. Study completion31 May 2017

Why it stopped: Unable to identify sufficient number of patients to enroll

Resources

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03146819
Sponsor's protocol ID
15-001
Status last verified
Oct 2023
First submitted
8 May 2017
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bourne 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 19844772

  • 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 17403800

  • Lepage C, Noreau L, Bernard PM. Association between characteristics of locomotion and accomplishment of life habits in children with cerebral palsy. Phys Ther. 1998 May;78(5):458-69. doi: 10.1093/ptj/78.5.458.

    PubMed 9597060

  • McCarthy CJ, Oldham JA. The reliability, validity and responsiveness of an aggregated locomotor function (ALF) score in patients with osteoarthritis of the knee. Rheumatology (Oxford). 2004 Apr;43(4):514-7. doi: 10.1093/rheumatology/keh081. Epub 2004 Jan 13.

    PubMed 14722348

  • Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.

    PubMed 20851566

  • Noble 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

  • Nordin E, Rosendahl E, Lundin-Olsson L. Timed "Up & Go" test: reliability in older people dependent in activities of daily living--focus on cognitive state. Phys Ther. 2006 May;86(5):646-55.

    PubMed 16649889

  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946

  • Suda AJ, Seeger JB, Bitsch RG, Krueger M, Clarius M. Are patients' expectations of hip and knee arthroplasty fulfilled? A prospective study of 130 patients. Orthopedics. 2010 Feb;33(2):76-80. doi: 10.3928/01477447-20100104-07.

    PubMed 20192137

  • Wall JC, Bell C, Campbell S, Davis J. The Timed Get-up-and-Go test revisited: measurement of the component tasks. J Rehabil Res Dev. 2000 Jan-Feb;37(1):109-13.

    PubMed 10847578

  • Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.

    PubMed 17057533

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 4 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: 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?

The study was stopped early (reason given: Unable to identify sufficient number of patients to enroll). Results are not available in the source record.

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 testing differences (time frame: At least 6 months post-surgery). 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 NCT03146819, which also lists 11 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in