iDuo^® G2 Bicompartmental Knee Resurfacing Device

The iDuo G2 bicompartmental resurfacing device is an implant designed for the treatment of moderate to severe osteoarthritis. It is a unique treatment alternative for patients with arthritic damage or worn cartilage affecting one of the tibiofemoral compartments and the patellofemoral compartment. Together with the iUni G2, the iDuo provides surgeons with a range of partial knee resurfacing options.

iDuo Implant with Matching iJig Femoral Cutting Guide

An estimated 30% of patients with advanced osteoarthritis have cartilage damage affecting one of the tibiofemoral compartments in addition to the patellofemoral compartment.1 Traditionally, if the patellofemoral compartment was affected by osteoarthritis, with one of the tibiofemoral compartments, a total knee replacement was the only available treatment. The iDuo eliminates the need to move to a total knee procedure when one of the tibiofemoral compartments still has viable and functioning cartilage.

Combining proven TKR principles for patella treatment with the unique advantages of a ConforMIS, partial knee system, ConforMIS has developed the only personalized bicompartmental knee implant designed to conform precisely to your own unique anatomy.

How it Works

The patient-specific iDuo G2 is designed from a CT scan of an individual patient's knee using the ConforMIS iFit technology. The iFit design process interactively maps the diseased joint, using the patient-specific bone geometry to define the shape and size of the femoral and tibial components as well as the patient-specific instrumentation.

The cobalt chrome femoral component conforms to the surface of the patient's femoral condyle, replacing the damaged cartilage with a smooth articulating surface. Because of its patient-specific conformity to the subchondral bone, it is a true resurfacing product, requiring only cartilage removal from the diseased area and two minimal bone cuts. The weight bearing portion of the subchondral plate is kept intact.

The patient-specific geometry of the tibial implant provides cortical rim coverage on the tibia, a result not previously achievable with off-the-shelf implants. Combined with the iJig guided surgical technique, the design principles for the tibial implant address one of the main contributors to increased risk of implant subsidence.

The unique design of the two components permits precise resurfacing of the affected compartments, while preserving the healthy cartilage and bone in the unaffected compartment. The iDuo G2 also preserves the anterior and posterior cruciate ligaments, allowing for more natural knee kinematics. Both features may be particularly important for younger, more active patients who are not yet indicated for total knee replacement.

iDuo G2 Features

• Available for the patellofemoral and medial or lateral compartments
• Preserves bone and cartilage in unaffected compartments and future surgical options
• Preserves anterior and posterior cruciate ligaments, helping to maintain knee kinematics
• Precise, anatomic fit to ensure ROM without impingement or overhang
• Complete cortical rim coverage to reduce risk of tibial implant subsidence and loosening
• Disposable, patient-specific iJig instrumentation with built-in image guidance
• Simple, reproducible surgical technique
• Potential for less post-operative pain and shorter post-operative recovery time

Who is a Candidate

The iDuo G2 was developed for patients with advanced osteoarthritis affecting one of the tibiofemoral compartments along with the patellofemoral compartment. The bone and cartilage preserving features of the iDuo G2 may be especially valuable for young and active patients who are considered too early for traditional knee replacement, but who suffer from arthritis in one or two compartments. The iDuo G2 allows the patient to preserve their joint for future surgical options, while receiving an implant with the potential to prevent or delay the need for a more invasive surgery.

Intended Use

The ConforMIS iDuo G2 Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as a unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

• painful joint disease due to osteoarthritis
• traumatic arthritis of the knee
• post traumatic loss of joint function
• failed osteotomies, hemiarthoplasties and Unicondylar implants

The iDuo G2 Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and patellofemoral areas have been affected by one or more of the above noted conditions.

The iDuo G2 implant is intended for cemented use only.

Contraindications

Absolute

• Active or recent local or systemic infection
• Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
• Severe instability due to advanced loss of osteochondral structure or the absence of collateral ligament integrity
• Severe (>15°) fixed valgus or varus deformity.
  

Relative

• Tricompartmental disease > Grade III