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

Primary Purpose

Knee Osteoarthritis

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

iPoly XE tibial insert with ConforMIS iTotal KRS

About this trial

This is an interventional basic science trial for Knee Osteoarthritis focused on measuring knee implant, osteoarthritis, patient-specific, knee osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical condition included in the approved Indications For Use for the iTotal® CR
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)
Compromised PCL or collateral ligament
Severe fixed valgus or varus deformity of >15º
Extensor lag > 15º
Fixed flexion contracture ≥ 15º
Unwilling or unable to comply with study requirements
Participation in another clinical study which would confound results
Allergy to any of the implant materials

Sites / Locations

University Medical Center of Johannes Gutenberg-University Mainz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ConforMIS iTotal Knee with iPoly Insert

Arm Description

The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03289754

First Posted

September 15, 2017

Last Updated

October 23, 2023

Sponsor

Restor3D

1. Study Identification

Unique Protocol Identification Number

NCT03289754

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Decision of investigational team

Study Start Date

January 24, 2018 (Actual)

Primary Completion Date

June 9, 2022 (Actual)

Study Completion Date

June 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Restor3D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

knee implant, osteoarthritis, patient-specific, knee osteoarthritis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ConforMIS iTotal Knee with iPoly Insert

Arm Type

Experimental

Arm Description

The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.

Intervention Type

Device

Intervention Name(s)

iPoly XE tibial insert with ConforMIS iTotal KRS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline to 1-year in Knee Society Score

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change from baseline score in Knee Society Score at year 2

Description

Time Frame

2 years

Title

Change from baseline score in Knee Society Score at year 5

Description

Time Frame

5 years

Title

Change from baseline score in Knee Society Score at year 10

Description

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical condition included in the approved Indications For Use for the iTotal® CR 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) Compromised PCL or collateral ligament Severe fixed valgus or varus deformity of >15º Extensor lag > 15º Fixed flexion contracture ≥ 15º Unwilling or unable to comply with study requirements Participation in another clinical study which would confound results Allergy to any of the implant materials

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philipp Drees

Organizational Affiliation

University- Mainz

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center of Johannes Gutenberg-University Mainz

City

Mainz

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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