Status:
TERMINATED
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Lead Sponsor:
Restor3D
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
Detailed Description
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed re...
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 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 \> 15 º
- Fixed flexion contracture ≥ 15 º
- 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 :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT01820650
Start Date
February 1 2013
End Date
October 1 2023
Last Update
October 25 2023
Active Locations (9)
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1
JFK Medical Center
Atlantis, Florida, United States, 33462
2
EMMC - Orthopaedic Surgery of Maine
Bangor, Maine, United States, 04401
3
Great Lakes Bone and Joint
Battle Creek, Michigan, United States, 49015
4
Orthopaedic Instatute of Henderson
Henderson, Nevada, United States, 89052