Clinical trial NCT00765362: Mobile - Bearing Knee Study
Official title: Encore Mobile - Bearing Knee Study #200
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Tissue Disorder
Osteoarthritis
Avascular Necrosis
Post-traumatic Arthritis
Secondary Arthritis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.


Eligibility criteria: Inclusion Criteria:

* Skeletal maturity
* Less than 70 on preoperative Knee Society Score (Rating Score)
* Sufficient bone stock, as judged by radiographs, to support primary knee implant
* Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
* Patient is not pregnant
* Primary total knee replacement
* Sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
* Varus deformity \<45 or valgus deformity \<45 or fixed flexion deformity \<90
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Skeletal immaturity
* Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)
* Previous knee surgery that has adversely affected bone stock or prior total knee replacement
* Post patellectomy
* Patient is pregnant
* Insufficient collateral ligaments, as judged by the physician
* Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity).
* Varus deformity \>45 or valgus deformity \>45 or fixed flexion deformity \>90.
* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and Alzheimer's Disease).
* Prisoners
* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).

Primary outcomes:
measure: Knee Society Score Evaluation
timeFrame: 2 year
measure: Knee Society Function Score
timeFrame: 2 year
measure: Knee Society Scores Used as Success/Failure Criteria.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden VA Hospital
state: Arizona
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Miami
country: United States
facility: S.Florida VA Found. For Research & Education, Inc.
state: Florida
city: Garden City
country: United States
facility: Great Lakes Orthopaedics
state: Michigan
city: Hilton Head Island
country: United States
state: South Carolina
city: Edinburg
country: United States
facility: Orthopedic Surgery Center and Sports Medicine
state: Texas
city: Murray
country: United States
facility: The Orthopedic Specialty Hospital
state: Utah
city: West Jordan
country: United States
state: Utah
Study officials:
References: