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

NCT03146819 | Terminated FDA Device

• 1 other identifier: 15-001
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; osteoarthritis knee; total knee replacement; patient specific; total knee arthroplasty; orthopedics

Outcome Measures

Primary Outcomes (1)

• Functional testing differences

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

  At least 6 months post-surgery

Secondary Outcomes (2)

• Knee Society Clinical Rating Score

  At least 6 months post-surgery

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  At least 6 months post-surgery

Study Arms (2)

iTotal PS KRS

Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing.

Device: iTotal PS Knee Replacement System

Off-the-Shelf KRS

Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing.

Device: Off-the-Shelf Knee Replacement System

Interventions

iTotal PS Knee Replacement System DEVICE

Total Knee Replacement systems (Patient Specific)

iTotal PS KRS

Off-the-Shelf Knee Replacement System DEVICE

Total Knee Replacement systems (Off-the-shelf)

Off-the-Shelf KRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (1)

Bethesda Orthopedic

Bethesda, Maryland, 20817, United States

Location

Related Publications (11)

• 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.

  PMID: 19844772 BACKGROUND

• 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.

  PMID: 17403800 BACKGROUND

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  PMID: 9597060 BACKGROUND

• 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.

  PMID: 14722348 BACKGROUND

• 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.

  PMID: 20851566 BACKGROUND

• 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.

  PMID: 16967035 BACKGROUND

• 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.

  PMID: 16649889 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 20192137 BACKGROUND

• 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.

  PMID: 10847578 BACKGROUND

• 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.

  PMID: 17057533 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christopher Cannova, MD

  Bethesda Orthopedic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: December 16, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)