Prospective Randomized Study of Cementless vs Cemented UKA

This is an interventional treatment trial for Osteoarthritis, Knee Read More

Inclusion Criteria:

• Patients with a pre-operative Knee Society Assessment Score of <70
• Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
• Patients diagnosed with osteoarthritis (Kellgren Lawrence Grade IV) or avascular necrosis limited to the medial compartment of the operative knee joint
• Male or female patients who are at least 21 years of age at the time of surgery
• Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
• Patients with functionally intact ACL and PCL
• Patients who need to obtain relief of pain and/or improved function in their knee
• Patients with fixed flexion deformity < 15°
• Patients who are able to follow post operative care instructions
• Patients who are willing and able to return for scheduled follow-up evaluations
• Patients in which natural alignment can be restored
• Patients with BMI < 40
• Patients who have completed a valid, IRB approved Informed Consent Form

Exclusion Criteria:

• Patients with a pre-operative Knee Society Assessment Score of ≥ 70
• Patients in which the device would be used to revise a failed prosthesis
• Patients who are less than 21 years of age at the time of surgery
• Disease or damage to the lateral part of the knee that in the investigator's opinion contraindicates a partial knee replacement
• Patients diagnosed with rheumatoid arthritis or other forms of inflammatory joint disease
• Patients diagnosed with a failed upper tibial osteotomy in the operative knee
• Patients diagnosed with post-traumatic arthritis after tibial plateau fracture
• Patients who have had a patellectomy
• Patients with a flexion deformity > 15°
• Patients with a fixed varus deformity > 15°
• Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Patients with a fused knee on operative side
• Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk.
• Patient with pre-existing condition(s) that may interfere with the survival of the implant or their outcomes, including: Sickle Cell Anemia, Lower extremity muscular atrophy, Neuromuscular disease, Vascular insufficiency, Metabolic Disorders which impair bone formation, Paget's Disease, Charcot's Disease, Osteomalacia, Osteoporosis, Osteopenia.
• Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including: Immuno-compromised conditions (i.e. HIV), Hepatitis, Tuberculosis, Neoplastic disease such as cancer of the prostate, lung, stomach, cervix, etc.
• Chronic renal failure
• Organ transplant (i.e., heart, liver, lung, etc.) recipients
• Known disease process that in the opinion of the investigator may limit long term (4 year) follow up (i.e., multiple sclerosis, leukemia, lymphoma, etc.)
• Patients diagnosed with Parkinson's or Alzheimer's Disease
• Patients who have had an above-knee amputation in the contralateral leg Instability or deformity of the ligaments and/or surrounding soft tissue, which would preclude stability of the prostheses
• Patients with a known metal allergy
• Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent
• Patients who have received systemic steroids within the past 6 months or steroid injection into the affected knee within the previous 6 weeks prior to enrollment
• Patients taking immunosuppressives
• Patients who are pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
• Patients with severe valgus or varus knees (valgus or varus angulation of more than 20°) where collateral ligament, iliotibial band, or popliteal release is required
• Patients who refuse to sign the IRB approved Informed Consent Form
• Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months
• Patients with a history of osteomyelitis or sepsis of the index knee
• Patients who require patellar resurfacing
• Patients who are not skeletally mature
• Patients who have had a total hip replacement procedure <18 months prior to entering the study
• Patients who have had a contralateral non-study knee replacement procedure <18 months prior to entering the study
• Patients who are found intraoperatively to have inadequate bone stock or other conditions that contraindicate a partial knee replacement
• Patients who have a higher risk of falling
• Patients who are smokers or a history of smoking in the past 12 months
• Patients with alcoholism or drug addiction
• Tumors of the supporting bone structures
• Patients who have a permanent valgus or varus deformity including tibia vara deformity
• Patients with BMI ≥ 40
• Patients 80 years of age or older
• Patients who have undergone same-day or staged bi-lateral partial knee replacement
• Patients who may have an allergic reaction to the device materials or bone cement