Clinical trial NCT01473134: Safety and Efficacy of the Oxford Cementless Partial Knee System
Official title: A Randomized Clinical Study to Compare the Safety and Efficacy of the Oxford Cementless Partial Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Avascular Necrosis of the Medial Femoral Condyle
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic Success
timeFrame: 2 years
measure: Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE)
timeFrame: 2 Years
measure: The Knee Society Assessment Score
timeFrame: 2 Years
measure: The Knee Society Function Score
timeFrame: 2 Year
Secondary outcomes:
measure: Knee Society Assessment Score
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
measure: Knee Society Score Assessment for Bilateral Subjects
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
measure: Knee Society Function Score at All Timepoints
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
measure: Knee Society Function Score for Bilateral Subjects
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
measure: Oxford Knee Score
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
measure: Number of Knees Which Met the Criteria for Radiographic Success
timeFrame: Pre-operation (baseline), 6 weeks, 6 months, 1y, 3y, 4y, 5y, 6y, 7y
measure: Patient Assessment of Satisfaction
timeFrame: 6 weeks, 6 months, and annually thereafter until study completion
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Orthopedic & Sports Medicine Center of Northern Indiana, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Center for Hip and Knee Surgery
state: Indiana
city: Council Bluffs
country: United States
facility: Miller Orthopaedic Affiliates
state: Iowa
city: Edina
country: United States
facility: Twin City Orthopedics
state: Minnesota
city: Huntersville
country: United States
facility: OrthoCarolina
state: North Carolina
city: New Albany
country: United States
facility: Joint Implant Surgeons, Inc
state: Ohio
city: Plano
country: United States
facility: Texas Center for Joint Replacements
state: Texas
city: Alexandria
country: United States
facility: Anderson Orthopedic Clinic
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: