OrthoGlide® Medial Knee Implant

Inclusion – Exclusion Criteria 1.0 Inclusion Criteria (the patient must meet all of the following criteria) 1.1 1.2 1.3 1.4 1.5 1.6 The patient is at least 30 years old. The patient has grade II to IV osteoarthritis of the medial compartment of the knee. The patient has an anatomic angular deformity of 4° varus to 2° valgus as determined by standing knee weight bearing x-ray films. Patient has significant pain of the medial knee compartment. The patient is a candidate for a uni-condylar implant, TKR, interpositional arthroplasty or high tibial osteotomy. The patient has undergone the appropriate pre-operative laboratory testing to confirm they are an appropriate patient to under go surgery as confirmed by the surgeon.

2.0

Exclusion Criteria (the presence of any of these findings excludes the patient from the study). 2.1 2.2 Patients with a history or evidence of: rheumatoid arthritis, pseudo-gout, any inflammatory arthritis, or any connective tissue disorder. The patient has significant bone-on-bone osteoarthritic involvement of the lateral compartment or the patellofemoral compartment of the study knee as confirmed by x-ray, MRI or at arthroscopy. The patient has an ACL, PCL, LCL, or MCL deficient knee. Patient may also be excluded for this abnormality at the time of surgery. The patient has excessive ligamentous laxity in the anteroposterior or mediolateral direction as determined by physical exam. There is a collapse or loss of contour of the tibial plateau and femoral condyle. The patient has an immobile or absent patella. The patient has significant osteoarthritis or a poorly functioning prosthesis of the hip(s) or ankle(s) which makes it difficult to evaluate the effect of the implant on the study knee. The patient has had an infection of the study knee joint at any time, or an infection in any joint in the previous six months.

2.3 2.4 2.5 2.6 2.7

2.8

2.9 2.10 2.11

The patient has sub-chondral cysts greater than 5 mm in size. The patient has a subluxation of the tibia relative to the femur. The patient has had any other surgical procedures during the three months prior to the planned surgery that would increase the risk of infection, or interfere with patient evaluation or recovery. The patient has an active, uncontrolled psychiatric or personality disorder. The patient has greater than 10° active extension deficit. The patient has less than 100° minimum active range of motion. The patient has osteopenia as confirmed by x-ray. The patient had prior surgery to the study knee to place a prosthesis in the patellofemoral or the lateral compartment or the patient has had a high tibial osteotomy. The patient’s medial tibial plateau size / shape is not appropriate for the size of the available implants; AP dimension less than 39 mm (for a 42 mm implant) or greater than 58 mm (58 mm implant). There are any anatomic or functional characteristics that make implantation of the device. The patient has clinically significant pain in the patellofemoral compartment. _

2.12 2.13 2.14 2.15 2.16

2.17

2.18