Trial Outcomes & Findings for Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System (NCT NCT00487565)

NCT ID: NCT00487565

Last Updated: 2013-08-14

Results Overview

Active flexion is measured by how much a patient can bend their knee on their own, without assistance.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 210 participants
• Primary outcome timeframe: 12 month
• Results posted on: 2013-08-14

Participant Flow

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.

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.

Participant milestones

Measure	LCS Complete Posterior Stabilized Knee Implant Total knee arthroplasty with a posterior stabilized implant
Overall Study STARTED	210
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	LCS Complete Posterior Stabilized Knee Implant n=210 Participants Total knee arthroplasty with a posterior stabilized implant
Age Continuous Age	63.8 participants STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants
Region of Enrollment United States	180 participants n=5 Participants
Region of Enrollment Switzerland	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

Active flexion is measured by how much a patient can bend their knee on their own, without assistance.

Outcome measures

Measure	LCS Complete Posterior Stabilized Knee Implant n=182 Participants Total knee arthroplasty with a posterior stabilized implant
Knee Active Flexion	119.2 degrees Standard Deviation 9.9

Adverse Events

LCS Complete Posterior Stabilized Knee Implant

Serious events: 28 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	LCS Complete Posterior Stabilized Knee Implant n=210 participants at risk Total knee arthroplasty with a posterior stabilized implant
Cardiac disorders Cardiac	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Gastrointestinal disorders Gastrointestinal	1.9% 4/210 • Number of events 4 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Hemarthrosis	0.95% 2/210 • Number of events 2 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Musculoskeletal	4.8% 10/210 • Number of events 10 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other-Arthrofibrosis	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other - Dehiscence Arthrotomy	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other - Distal Screw Failed at the Tuberocitas Osteotomy	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other - Loose Cement	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other - Polyethylene Spin Out After Fainting	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other- Subpatellar Crepitation	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Musculoskeletal and connective tissue disorders Other - Wound Dehiscence	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.95% 2/210 • Number of events 2 • In this study adverse events were reporting for the length of the study which was one year. 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).
Nervous system disorders Neurological	1.4% 3/210 • Number of events 3 • In this study adverse events were reporting for the length of the study which was one year. 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).
Respiratory, thoracic and mediastinal disorders Respiratory System	0.48% 1/210 • Number of events 1 • In this study adverse events were reporting for the length of the study which was one year. 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).

Other adverse events

Measure

LCS Complete Posterior Stabilized Knee Implant n=210 participants at risk Total knee arthroplasty with a posterior stabilized implant

Musculoskeletal and connective tissue disorders Musculoskeletal

5.2% 11/210 • Number of events 13 • In this study adverse events were reporting for the length of the study which was one year. 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).

Additional Information

Tammy O'Dell

DePuy Orthopaedics, Inc.

Phone: 574-372-7104

Email: TOdell2@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60