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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03289754
• Other study ID #: 16-001
• Status: Terminated
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: June 9, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center of Johannes Gutenberg-University Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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