A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts

This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: iPoly XE tibial insert with ConforMIS iTotal KRS

Detailed Description

The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany
    • University Medical Center of Johannes Gutenberg-University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use for the iTotal® CR
2. 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.
3. Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
4. > 18 years of age

Exclusion Criteria:

1. Simultaneous bilateral procedure required
2. BMI > 40
3. 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
4. Poorly controlled diabetes
5. Neuromuscular conditions which prevent patient from participating in study activities
6. Active local or systemic infection
7. Immunocompromised
8. Fibromyalgia or other general body pain related condition
9. Rheumatoid arthritis or other forms of inflammatory joint disease
10. 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
11. Diagnosed with or receiving treatment for Osteoporosis
12. Other physical disability affecting the hips, spine, or contralateral knee
13. Severe instability due to advanced loss of osteochondral structure
14. Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
15. Compromised PCL or collateral ligament
16. Severe fixed valgus or varus deformity of >15º
17. Extensor lag > 15º
18. Fixed flexion contracture ≥ 15º
19. Unwilling or unable to comply with study requirements
20. Participation in another clinical study which would confound results
21. Allergy to any of the implant materials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ConforMIS iTotal Knee with iPoly Insert; The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.

Device: iPoly XE tibial insert with ConforMIS iTotal KRS; The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to 1-year in Knee Society Score	Change in Knee Society Score from baseline (12 weeks post implantation) to 1 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline score in Knee Society Score at year 2	Change in Knee Society Score from baseline (12 weeks post implantation) to 2 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.	2 years
Change from baseline score in Knee Society Score at year 5	Change in Knee Society Score from baseline (12 weeks post implantation) to 5 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.	5 years
Change from baseline score in Knee Society Score at year 10	Change in Knee Society Score from baseline (12 weeks post implantation) to 10 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.	10 years

Collaborators and Investigators

• Sponsor: Restor3D
• Investigators: Principal Investigator: Philipp Drees, University- Mainz

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; knee osteoarthritis; patient-specific; knee implant
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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