A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/4/2018 |
Start Date: | February 2013 |
End Date: | March 2026 |
This study is designed to observe the long term clinical outcomes of patient-specific knee
arthroplasty in patients with osteoarthritis.
arthroplasty in patients with osteoarthritis.
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 regarding BOTH their iTotal® CR knee and their standard
total knee for all time points where questionnaires are required by the protocol.
contralateral knee, the primary endpoint questionnaire and some secondary endpoint
questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard
total knee for all time points where questionnaires are required by the protocol.
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 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
We found this trial at
9
sites
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