7/31/2019 OrthoGlide Medial Knee Implant - Inclusion - Exclusion Criteria

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OrthoGlideMedial Knee Implant

Inclusion Exclusion Criteria

1.0 Inclusion Criteria (the patient must meet all of the following criteria)

1.1 The patient is at least 30 years old.

1.2 The patient has grade II to IV osteoarthritis of the medial compartment of the kne

1.3 The patient has an anatomic angular deformity of 4 varus to 2 valgus asdetermined by standing knee weight bearing x-ray films.

1.4 Patient has significant pain of the medial knee compartment.

1.5 The patient is a candidate for a uni-condylar implant, TKR, interpositionalarthroplasty or high tibial osteotomy.

1.6 The patient has undergone the appropriate pre-operative laboratory testing toconfirm they are an appropriate patient to under go surgery as confirmed by thesurgeon.

2.0 Exclusion Criteria (the presence of any of these findings excludes the patient from thestudy).

2.1 Patients with a history or evidence of: rheumatoid arthritis, pseudo-gout, anyinflammatory arthritis, or any connective tissue disorder.

2.2 The patient has significant bone-on-bone osteoarthritic involvement of the lateralcompartment or the patellofemoral compartment of the study knee as confirmed by

x-ray, MRI or at arthroscopy.

2.3 The patient has an ACL, PCL, LCL, or MCL deficient knee. Patient may also beexcluded for this abnormality at the time of surgery.

2.4 The patient has excessive ligamentous laxity in the anteroposterior or mediolateraldirection as determined by physical exam.

2.5 There is a collapse or loss of contour of the tibial plateau and femoral condyle.

2.6 The patient has an immobile or absent patella.

2.7 The patient has significant osteoarthritis or a poorly functioning prosthesis of thehip(s) or ankle(s) which makes it difficult to evaluate the effect of the implant on thestudy knee.

2.8 The patient has had an infection of the study knee joint at anytime, or an infection in any joint in the previous six months.

7/31/2019 OrthoGlide Medial Knee Implant - Inclusion - Exclusion Criteria

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2.9 The patient has sub-chondral cysts greater than 5 mm in size.

2.10 The patient has a subluxation of the tibia relative to the femur.

2.11 The patient has had any other surgical procedures during the three months prior tothe planned surgery that would increase the risk of infection, or interfere with patien

evaluation or recovery.

2.12 The patient has an active, uncontrolled psychiatric or personality disorder.

2.13 The patient has greater than 10 active extension deficit.

2.14 The patient has less than 100 minimum active range of motion.

2.15 The patient has osteopenia as confirmed by x-ray.

2.16 The patient had prior surgery to the study knee to place a prosthesis in thepatellofemoral or the lateral compartment or the patient has had a

high tibial osteotomy.

2.17 The patients medial tibial plateau size / shape is not appropriate for the sizeof the available implants; AP dimension less than 39 mm (for a 42 mm implant) orgreater than 58 mm (58 mm implant). There are any anatomic or functionalcharacteristics that make implantation of the device.

2.18 The patient has clinically significant pain in the patellofemoral compartment._