Clinical trial NCT03289754: 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
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee implant
osteoarthritis
patient-specific
knee osteoarthritis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2017-09-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change from Baseline to 1-year in Knee Society Score
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline score in Knee Society Score at year 2
timeFrame: 2 years
measure: Change from baseline score in Knee Society Score at year 5
timeFrame: 5 years
measure: Change from baseline score in Knee Society Score at year 10
timeFrame: 10 years
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of Johannes Gutenberg-University Mainz
Study officials:
affiliation: University- Mainz
name: Philipp Drees
role: PRINCIPAL_INVESTIGATOR
References: