Study of the ConforMIS iDuo(R) G2

Stopped early

Conditions studied: Bicompartmental Osteoarthritis

In brief

To evaluate the ConforMIS iDuo G2 implant

Key facts

Study ID

NCT01564641

Run by

Restor3D

People needed

150

Starts

2012-05-01

Expected to finish

2022-11-18

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical condition included in the approved Indications For Use for the iDuo® G2
• Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
• Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
• > 18 years of age

You may not qualify if…

• 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 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
• Compromised ACL, PCL or collateral ligament
• Severe fixed valgus or varus deformity of >15º
• Extensor lag > 15 º
• Fixed flexion contracture ≥ 10 º
• Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results
• If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail

Where it is running

• Forest Ridge Medical Pavilion — New Castle, Indiana, United States
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States
• Mansfield Orthopaedics — Morrisville, Vermont, United States

Full record on ClinicalTrials.gov

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