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Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

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ClinicalTrials.gov Identifier: NCT00487565
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : March 23, 2012
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Arthritis
Intervention Device: Total knee arthroplasty
Enrollment 210
Recruitment Details Between September 2006 and February 2011, 210 subjects were recruited and enrolled at 4 clinics by orthopaedic surgeons. Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.
Pre-assignment Details This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the LCS Complete Posterior Stabilized implant. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.
Arm/Group Title LCS Complete Posterior Stabilized Knee Implant
Hide Arm/Group Description Total knee arthroplasty with a posterior stabilized implant
Period Title: Overall Study
Started 210
Completed 182
Not Completed 28
Arm/Group Title LCS Complete Posterior Stabilized Knee Implant
Hide Arm/Group Description Total knee arthroplasty with a posterior stabilized implant
Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Participants
Age Number Analyzed 210 participants
63.8  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
120
  57.1%
Male
90
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 210 participants
United States 180
Switzerland 30
1.Primary Outcome
Title Knee Active Flexion
Hide Description Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Time Frame 12 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LCS Complete Posterior Stabilized Knee Implant
Hide Arm/Group Description:
Total knee arthroplasty with a posterior stabilized implant
Overall Number of Participants Analyzed 182
Mean (Standard Deviation)
Unit of Measure: degrees
119.2  (9.9)
Time Frame In this study adverse events were reporting for the length of the study which was one year.
Adverse Event Reporting Description There were 30 total occurrences of which 14 were unique serious adverse events that affected 28 subjects (2 subjects experienced more than 1 serious adverse event). There were 13 total occurrences of other adverse events, of which 1 unique event (above the 5% threshold) affected 11 subjects (2 subjects experienced more than 1 other adverse event).
 
Arm/Group Title LCS Complete Posterior Stabilized Knee Implant
Hide Arm/Group Description Total knee arthroplasty with a posterior stabilized implant
All-Cause Mortality
LCS Complete Posterior Stabilized Knee Implant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LCS Complete Posterior Stabilized Knee Implant
Affected / at Risk (%) # Events
Total   28/210 (13.33%)    
Cardiac disorders   
Cardiac  1/210 (0.48%)  1
Gastrointestinal disorders   
Gastrointestinal  4/210 (1.90%)  4
Musculoskeletal and connective tissue disorders   
Hemarthrosis  2/210 (0.95%)  2
Musculoskeletal  10/210 (4.76%)  10
Other-Arthrofibrosis  1/210 (0.48%)  1
Other - Dehiscence Arthrotomy  1/210 (0.48%)  1
Other - Distal Screw Failed at the Tuberocitas Osteotomy  1/210 (0.48%)  1
Other - Loose Cement  1/210 (0.48%)  1
Other - Polyethylene Spin Out After Fainting  1/210 (0.48%)  1
Other- Subpatellar Crepitation  1/210 (0.48%)  1
Other - Wound Dehiscence  1/210 (0.48%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer  2/210 (0.95%)  2
Nervous system disorders   
Neurological  3/210 (1.43%)  3
Respiratory, thoracic and mediastinal disorders   
Respiratory System  1/210 (0.48%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LCS Complete Posterior Stabilized Knee Implant
Affected / at Risk (%) # Events
Total   11/210 (5.24%)    
Musculoskeletal and connective tissue disorders   
Musculoskeletal  11/210 (5.24%)  13
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
Name/Title: Tammy O'Dell
Organization: DePuy Orthopaedics, Inc.
Phone: 574-372-7104
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00487565     History of Changes
Other Study ID Numbers: 06005
LCS:PS
First Submitted: June 14, 2007
First Posted: June 18, 2007
Results First Submitted: February 21, 2012
Results First Posted: March 23, 2012
Last Update Posted: August 14, 2013