Clinical trial NCT03152162: A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
Official title: A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
patient-specific
knee replacement
TKA
knee arthroplasty
total knee replacement
posterior stabilized
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoarthritis of the knee

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.

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

Primary outcomes:
measure: Change in Baseline from 1-Year in KSS
timeFrame: 2 Years
Secondary outcomes:
measure: Change from baseline in KSS at years 2, 5 and 10 post-implantation
timeFrame: Up to 10 years
measure: Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation
timeFrame: Up to 10 years
measure: Post-operative limb alignment if long leg x-rays available
timeFrame: 2 years
measure: Length of hospital stay in hours
timeFrame: 1 year
measure: Blood loss during surgery
timeFrame: 1 year
measure: Transfusion rate
timeFrame: 1 year
Other outcomes:
measure: Revision rates post-implantation
timeFrame: Collected from the date of implantation to the end of the study. Up to 10 years.
measure: Length of procedure: Skin to Skin
timeFrame: 1 year
Locations:
city: Chapel Hill
country: United States
facility: UNC Orthopedics
state: North Carolina
city: Austin
country: United States
facility: Texas Institute for Hip & Knee Surgery
state: Texas
city: Morrisville
country: United States
facility: Mansfield Orthopaedics
state: Vermont
city: Huntington
country: United States
facility: Scott Orthopedic
state: West Virginia
Study officials:
affiliation: Restor3D
name: Marc Quartulli
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.