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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03146819
• Other study ID #: 15-001
• Status: Terminated
• Start date: December 16, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• iTotal PS Knee Replacement System
Total Knee Replacement systems (Patient Specific)
• Off-the-Shelf Knee Replacement System
Total Knee Replacement systems (Off-the-shelf)

Locations

Country	Name	City	State
United States	Bethesda Orthopedic	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional testing differences	Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants	At least 6 months post-surgery
Secondary	Knee Society Clinical Rating Score	Comparison of scores and sub-scores from the following questionnaires between the study arms	At least 6 months post-surgery
Secondary	The Knee Injury and Osteoarthritis Outcome Score (KOOS)	Comparison of scores and sub-scores from the following questionnaires between the study arms	At least 6 months post-surgery