Clinical trial NCT03152357: A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS
Official title: A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® CR (Cruciate Retaining) Knee Replacement Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Knee Osteoarthritis
Keywords: osteoarthritis
total knee arthroplasty
TKA
TKR
patient specific
Conformis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's over 18 that have undergone surgical implantation of a ConforMIS product

Brief summary: This study is designed to evaluate implant survivorship, patient satisfaction, and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.

Detailed description: This study is designed to evaluate implant survivorship, patient satisfaction and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.This study is a retrospective, single-center study, with one single remote follow up contact. Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available.

Eligibility criteria: Inclusion Criteria:

* Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement.
* Subject must be greater than 18 years of age.

Primary outcomes:
measure: Survivorship data
timeFrame: 1 year
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Preferred Orthopedics of the Palm Beaches
state: Florida
Study officials:
affiliation: JFK Medical Center
name: Gregory Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.