Mobile - Bearing Knee Study

Osteoarthritis Clinical Trial

Official title:

Encore Mobile - Bearing Knee Study #200

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765362
• Other study ID #: Study 200
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: May 10, 2011
• Start date: January 2000
• Est. completion date: August 2008

Study information

• Verified date: May 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Inflammatory Tissue Disorder
• Osteoarthritis
• Post-traumatic Arthritis
• Secondary Arthritis

Intervention

Device:
• Encore Mobile-Bearing Knee
Used for primary total knee replacement

Locations

Country	Name	City	State
United States	Orthopedic Surgery Center and Sports Medicine	Edinburg	Texas
United States	Orange Coast Memorial Medical Center	Fountain Valley	California
United States	Great Lakes Orthopaedics	Garden City	Michigan
United States	S.Florida VA Found. For Research & Education, Inc.	Miami	Florida
United States	The Orthopedic Specialty Hospital	Murray	Utah
United States	Carl T. Hayden VA Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score Evaluation	The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).	2 year	No
Primary	Knee Society Function Score	The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.	2 year	No
Primary	Knee Society Scores Used as Success/Failure Criteria.	The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.	2 year	No

External Links

•   Sponsor company home page