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

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

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.

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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

Resource links provided by the National Library of Medicine



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


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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152162


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

Locations
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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
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Study Director: Marc Quartulli ConforMIS, Inc.
Publications:
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT03152162    
Other Study ID Numbers: 14-003
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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