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

NCT03152162 | Terminated FDA Device

• 1 other identifier: 14-003
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; patient-specific; knee replacement; TKA; knee arthroplasty; total knee replacement; posterior stabilized

Outcome Measures

Primary Outcomes (1)

• Change in Baseline from 1-Year in KSS

  Change in Knee Society Scores from the pre-operative visit to the 1-year post-operative visit. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012).

  2 Years

Secondary Outcomes (6)

• Change from baseline in KSS at years 2, 5 and 10 post-implantation

  Up to 10 years

• Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation

  Up to 10 years

• Post-operative limb alignment if long leg x-rays available

  2 years

• Length of hospital stay in hours

  1 year

• Blood loss during surgery

  1 year

Other Outcomes (2)

• Revision rates post-implantation

  Collected from the date of implantation to the end of the study. Up to 10 years.

• Length of procedure: Skin to Skin

  1 year

Interventions

iTotal PS KRS DEVICE

Total knee arthroplasty for treatment of osteoarthritis

Also known as: ConforMIS iTotal PS

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

Patients with osteoarthritis of the knee

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (4)

UNC Orthopedics

Chapel Hill, North Carolina, 27599, United States

Location

Texas Institute for Hip & Knee Surgery

Austin, Texas, 78751, United States

Location

Mansfield Orthopaedics

Morrisville, Vermont, 05661, United States

Location

Scott Orthopedic

Huntington, West Virginia, 25702, United States

Location

Related Publications (7)

• 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

• 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

• 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

• 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

• 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.

  PMID: 22045067 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marc Quartulli

  Restor3D

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)