NCT01899417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

July 9, 2013

Last Update Submit

October 23, 2023

Conditions

Osteoarthritis,Knee

Keywords

osteoarthritisknee replacementpatient-specificeconomics

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    3 months

Study Arms (2)

ConforMIS iTotal® Knee Replacement

knee joint replacement

Device: ConforMIS iTotal® Knee Replacement

Standard Knee Replacements

knee joint replacement

Device: ConforMIS iTotal® Knee Replacement

Interventions

ConforMIS iTotal® Knee ReplacementDEVICE

Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.

Also known as: Total knee replacement, arthoplasty, TKA, iTotal, Standard total knee device
ConforMIS iTotal® Knee ReplacementStandard Knee Replacements

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.

You may qualify if:

  • 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

You may not qualify if:

  • Participation in another clinical study that could confound results
  • Patient is less than 3 months post-op

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Related Publications (6)

  • 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: 17403800BACKGROUND

  • Rougraff 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.

    PMID: 1959265BACKGROUND

  • Fitzpatrick 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.

    PMID: 17188876BACKGROUND

  • Fitz 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.

    PMID: 19182028BACKGROUND

  • 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: 19844772BACKGROUND

  • 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: 16967035BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Gregory Martin, MD

    JFK Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

US(1)