A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

NCT ID: NCT03152162

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2022-11-01

Brief Summary

This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

Detailed Description

The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

iTotal PS KRS

Total knee arthroplasty for treatment of osteoarthritis

Intervention Type: DEVICE

Other Intervention Names

ConforMIS iTotal PS

Eligibility Criteria

Inclusion Criteria

• Clinical condition included in the approved Indications For Use for the iTotal® PS
• Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
• Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
• > 18 years of age

Exclusion Criteria

• Simultaneous bilateral procedure required
• BMI > 40
• Active malignancy (defined as a history of any invasive malignancy - except non- melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
• Poorly controlled diabetes
• Neuromuscular conditions which prevent patient from participating in study activities
• Active local or systemic infection
• Immunocompromised
• Fibromyalgia or other general body pain related condition
• Rheumatoid arthritis or other forms of inflammatory joint disease
• Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
• Diagnosed with or receiving treatment for Osteoporosis
• Other physical disability affecting the hips, spine, or contralateral knee
• Severe instability due to advanced loss of osteochondral structure
• Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results
• Allergy to any of the implant materials

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restor3D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Quartulli

Role: STUDY_DIRECTOR

Restor3D

Locations

UNC Orthopedics

Chapel Hill, North Carolina, United States

Texas Institute for Hip & Knee Surgery

Austin, Texas, United States

Mansfield Orthopaedics

Morrisville, Vermont, United States

Scott Orthopedic

Huntington, West Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17403800 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1959265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17188876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19182028 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19844772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16967035 (View on PubMed)

Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society Knee Scoring System. Clin Orthop Relat Res. 2012 Jan;470(1):3-19. doi: 10.1007/s11999-011-2135-0. No abstract available.

Reference Type: BACKGROUND

PMID: 22045067 (View on PubMed)

Other Identifiers

14-003

Identifier Type: -

Identifier Source: org_study_id