Safety and Efficacy of the Oxford Cementless Partial Knee System

Zimmer Biomet

Status

Completed

Conditions

Avascular Necrosis of the Medial Femoral Condyle

Osteoarthritis, Knee

Treatments

Device: Oxford Cemented Partial Knee

Device: Oxford Cementless Partial Knee

Study type

Interventional

Funder types

Industry

Identifiers

NCT01473134

ORTHO.CR.US30 (Other Identifier)

IDE: G100123

Details and patient eligibility

About

The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).

Full description

Prospectively controlled, randomized Investigational study. Patients are asked to come in pre-operatively, surgery, 6 weeks, 6 months, 1 year, 2 years and annually until the last patient reaches their 2 year visit. Product has not been cleared for use.

Enrollment

320 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a preoperative 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 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 Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL)
Patients who needs to obtain relief of pain and/or improved function in their knee
Patients with fixed flexion deformity <15 degrees
Patients who are able to follow postoperative care instructions
Patients who are willing and able to return for scheduled follow-up evaluations
Patients in which natural alignment can be restored
Patients who have completed a valid, Institutional Review Board (IRB) approved Informed Consent Form
Patients with child-bearing potential who voluntarily agree to prevent pregnancy for 2 years following device implantation

Exclusion criteria

Patients with a preoperative Knee Society Assessment Score of greater than or equal to 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 degrees
Patients with a fixed varus deformity > 15 degrees
Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Patients with a fused knee on operative side(s)
Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk
Patients with pre-existing condition(s) that may interfere with the survival of the implants 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
- Severe Osteoporosis
Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including:
- Immunocompromised 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 injections into the affected knee within the previous 6 weeks prior to enrollment
Patients who are pregnant
Patients with severe valgus or varus knees (valgus or varus angulation of more than 20 degrees) 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