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

NCT ID: NCT03289754

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2022-06-09

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iPoly XE tibial insert with ConforMIS iTotal KRS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restor3D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Drees

Role: PRINCIPAL_INVESTIGATOR

University- Mainz

Locations

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-001

Identifier Type: -

Identifier Source: org_study_id