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

• ClinicalTrials.gov Identifier: NCT03152162
• Recruitment Status: Recruiting
• First Posted: May 12, 2017
• Last Update Posted: November 18, 2020
• Sponsor: ConforMIS, Inc.
• Information provided by (Responsible Party): ConforMIS, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Osteoarthritis, Knee	Device: iTotal PS KRS

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
• Actual Study Start Date: May 1, 2017
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: December 2029

Groups and Cohorts

Intervention Details:

• Device: iTotal PS KRS
  Total knee arthroplasty for treatment of osteoarthritis
  Other Name: ConforMIS iTotal PS

Outcome Measures

Primary Outcome Measures :

1. Change in Baseline from 1-Year in KSS [ Time Frame: 2 Years ]
   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).

Secondary Outcome Measures :

1. Change from baseline in KSS at years 2, 5 and 10 post-implantation [ Time Frame: Up to 10 years ]
   The Knee Society Score includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. 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. Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation [ Time Frame: Up to 10 years ]
   The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42 question knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems.
3. Post-operative limb alignment if long leg x-rays available [ Time Frame: 2 years ]
   Comparison of limb alignment between pre-operative and post-operative x-rays.
4. Length of hospital stay in hours [ Time Frame: 1 year ]
   How long the patient is in the hospital from the time of admission to the time of discharge.
5. Blood loss during surgery [ Time Frame: 1 year ]
   Estimated blood loss during surgery (mL)
6. Transfusion rate [ Time Frame: 1 year ]
   Rate of patients who require blood transfusions during surgery

Other Outcome Measures:

1. Revision rates post-implantation [ Time Frame: Collected from the date of implantation to the end of the study. Up to 10 years. ]
   Rate of patients that require a revision of the total knee replacement for any reason.
2. Length of procedure: Skin to Skin [ Time Frame: 1 year ]
   The duration of the knee arthroplasty starting from the time the surgeon makes the first incision and ending when the surgeon sutures the initial incision.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with osteoarthritis of the knee

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

Contacts and Locations

Contacts

Contact: Marc Quartulli; 781-345-9191; Marc.Quartulli@conformis.com

Locations

United States, North Carolina

UNC Orthopedics; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Julie Titter 919-966-5495 julie_titter@med.unc.edu

United States, Texas

Texas Institute for Hip & Knee Surgery; Recruiting

Austin, Texas, United States, 78751

Contact: Jake Rabin 512-583-0217 jrabin@orthoaustin.com

Principal Investigator: Eric M Heinrich, MD

United States, Vermont

Mansfield Orthopaedics; Recruiting

Morrisville, Vermont, United States, 05661

Contact: Leah Morse, MS, PA-C 802-888-8405 lemorse@chsi.org

Principal Investigator: Bryan Huber, MD

United States, West Virginia

Scott Orthopedic; Recruiting

Huntington, West Virginia, United States, 25702

Contact: Morgan Koontz 304-525-6905 ext 400 morgan@scottorthopedic.com

Sponsors and Collaborators

ConforMIS, Inc.

Investigators

• Study Director: Marc Quartulli; ConforMIS, Inc.

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: ConforMIS, Inc.
• ClinicalTrials.gov Identifier: NCT03152162
• Other Study ID Numbers: 14-003
• First Posted: May 12, 2017
• Last Update Posted: November 18, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by ConforMIS, Inc.:

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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases