A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2023-10-31

Brief Summary

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This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

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Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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iTotal G2 CR Knee Replacement System

Total Knee replacement

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No