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Mobile - Bearing Knee Study

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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.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammatory Tissue Disorder
Osteoarthritis
Avascular Necrosis
Post-traumatic Arthritis
Secondary Arthritis
Intervention Device: Encore Mobile-Bearing Knee
Enrollment 419
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Period Title: Overall Study
Started 419
Completed 282
Not Completed 137
Reason Not Completed
Death             9
Adverse Event             2
Protocol Violation             18
Withdrawal by Subject             13
Lost to Follow-up             95
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Number of Baseline Participants 419
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419 participants
<=18 years
0
   0.0%
Between 18 and 65 years
181
  43.2%
>=65 years
238
  56.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 419 participants
66.8  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419 participants
Female
229
  54.7%
Male
190
  45.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 419 participants
419
1.Primary Outcome
Title Knee Society Score Evaluation
Hide Description 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).
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description:
Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: Average Knee Rating Score
93.1  (9.9)
2.Primary Outcome
Title Knee Society Function Score
Hide Description 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.
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description:
Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: Average Knee Function Score
89.0  (15.6)
3.Primary Outcome
Title Knee Society Scores Used as Success/Failure Criteria.
Hide Description 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.
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description:
Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Participants with Success
Knee Society Score Success 91
Knee Function Score Success 84
Time Frame Adverse events were collected from the date of surgery through the 2 year visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mobile Bearing Knee
Hide Arm/Group Description Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
All-Cause Mortality
Mobile Bearing Knee
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Mobile Bearing Knee
Affected / at Risk (%) # Events
Total   0/419 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Mobile Bearing Knee
Affected / at Risk (%) # Events
Total   281/419 (67.06%)    
Blood and lymphatic system disorders   
Edema  13/419 (3.10%)  13
Cardiac disorders   
Heart Complications  10/419 (2.39%)  10
Immune system disorders   
Cancer  10/419 (2.39%)  10
Infections and infestations   
Infections  16/419 (3.82%)  16
Injury, poisoning and procedural complications   
Knee device clicking  9/419 (2.15%)  9
Musculoskeletal and connective tissue disorders   
Arthrofibrosis  12/419 (2.86%)  13
Degenerative Arthritis  8/419 (1.91%)  9
Fracture  8/419 (1.91%)  8
Musculoskeletal pain  203/419 (48.45%)  328
Nervous system disorders   
Neurological disorder and numbness  11/419 (2.63%)  11
Vascular disorders   
Swelling  19/419 (4.53%)  20
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager of Clinical Affairs
Organization: DJO Surgical
Phone: 512-832-9500 ext 1323
EMail: jane.jacob@djosurgical.com
Layout table for additonal information
Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00765362    
Other Study ID Numbers: Study 200
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: June 16, 2010
Results First Posted: April 19, 2011
Last Update Posted: May 11, 2011