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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03152162
• Other study ID #: 14-003
• Status: Terminated
• Start date: May 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Texas Institute for Hip & Knee Surgery	Austin	Texas
United States	UNC Orthopedics	Chapel Hill	North Carolina
United States	Scott Orthopedic	Huntington	West Virginia
United States	Mansfield Orthopaedics	Morrisville	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Revision rates post-implantation	Rate of patients that require a revision of the total knee replacement for any reason.	Collected from the date of implantation to the end of the study. Up to 10 years.
Other	Length of procedure: Skin to Skin	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.	1 year
Primary	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	Change from baseline in KSS at years 2, 5 and 10 post-implantation	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).	Up to 10 years
Secondary	Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation	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.	Up to 10 years
Secondary	Post-operative limb alignment if long leg x-rays available	Comparison of limb alignment between pre-operative and post-operative x-rays.	2 years
Secondary	Length of hospital stay in hours	How long the patient is in the hospital from the time of admission to the time of discharge.	1 year
Secondary	Blood loss during surgery	Estimated blood loss during surgery (mL)	1 year
Secondary	Transfusion rate	Rate of patients who require blood transfusions during surgery	1 year