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Mobile - Bearing Knee Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765362
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : April 19, 2011
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:
Encore Medical, L.P.

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 2, 2008
Results First Submitted Date  ICMJE June 16, 2010
Results First Posted Date  ICMJE April 19, 2011
Last Update Posted Date May 11, 2011
Study Start Date  ICMJE January 2000
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • Knee Society Score Evaluation [ Time Frame: 2 year ]
    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).
  • Knee Society Function Score [ Time Frame: 2 year ]
    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.
  • Knee Society Scores Used as Success/Failure Criteria. [ Time Frame: 2 year ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
The Mobile-Bearing Knee will perform as well as the Foundation Total Knee at the 2-year evaluation [ Time Frame: 2 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile - Bearing Knee Study
Official Title  ICMJE Encore Mobile - Bearing Knee Study #200
Brief Summary To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Tissue Disorder
  • Osteoarthritis
  • Avascular Necrosis
  • Post-traumatic Arthritis
  • Secondary Arthritis
Intervention  ICMJE Device: Encore Mobile-Bearing Knee
Used for primary total knee replacement
Other Name: MBK
Study Arms  ICMJE Experimental: 1
Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.
Intervention: Device: Encore Mobile-Bearing Knee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2008)
419
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765362
Other Study ID Numbers  ICMJE Study 200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane M. Jacob Ph.D., DJO Surgical
Study Sponsor  ICMJE Encore Medical, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Encore Medical, L.P.
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP