Status:
TERMINATED
A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts
Lead Sponsor:
Restor3D
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03289754
Start Date
January 24 2018
End Date
June 9 2022
Last Update
October 16 2025
Active Locations (1)
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1
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, Germany