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

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Device: iPoly XE tibial insert with ConforMIS iTotal KRS

• Registration Number: NCT03289754
• Lead Sponsor: Restor3D

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-21
• Study Start: 2018-01-24
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 1-year in Knee Society Score	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline score in Knee Society Score at year 5	5 years	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.
Change from baseline score in Knee Society Score at year 2	2 years	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.
Change from baseline score in Knee Society Score at year 10	10 years	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.

Trial Locations

Locations (1)

University Medical Center of Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Germany