A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS

NCT03152357 | Completed FDA Device

• 1 other identifier: 16-003
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Knee Osteoarthritis

Keywords

osteoarthritis; total knee arthroplasty; TKA; TKR; patient specific; Conformis

Outcome Measures

Primary Outcomes (1)

• Survivorship data

  Survivorship of the implant--whether or not the patient has had a surgical revision prior to data collection.

  1 year

Secondary Outcomes (1)

• Patient Reported Outcomes

  1 year

Study Arms (1)

Patients implanted with a ConforMIS device

Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement

Device: ConforMIS iUni, iDuo, or iTotal (CR)

Interventions

ConforMIS iUni, iDuo, or iTotal (CR) DEVICE

ConforMIS iUni, iDuo, or iTotal (CR)

Patients implanted with a ConforMIS device

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

Patient's over 18 that have undergone surgical implantation of a ConforMIS product

You may qualify if:

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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (1)

Preferred Orthopedics of the Palm Beaches

Boynton Beach, Florida, 33437, 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: 17403800 BACKGROUND

• 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: 17188876 BACKGROUND

• 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: 19182028 BACKGROUND

• 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: 1959265 BACKGROUND

• 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

• 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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gregory Martin, MD

  JFK Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: April 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: December 31, 2019
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)