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

• Sponsor: DePuy Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00487565
• Collaborator: (none)
• Enrollment: 210
• Locations: 3
• Arm: 1
• Duration (Months): 53
• Patients Per Site: 70
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Juvenile Arthritis	Device: Total knee arthroplasty	N/A

Detailed Description

Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: LCS Complete Posterior Stabilized knee implant Total knee arthroplasty with a posterior stabilized implant	Device: Total knee arthroplasty; Total knee arthroplasty using a posterior stabilized implant; Other Names: LCS® Complete Posterior Stabilized Mobile-bearing Knee

Outcome Measures

Primary Outcome Measures

1. Knee Active Flexion [12 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• M/F

• 18-80

• Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.

• Skeletally mature, sufficient bone stock to seat and support prosthesis

• Willing/able return for follow-up.

• Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria:

• History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue

• Communicable diseases that may limit follow-up

• Medical-legal or workers compensation claims.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Joint Replacement	Denver	Colorado	United States	80210
2	Joint Reconstruction Center	Pittsburgh	Pennsylvania	United States	15260
3	Jordan-Young Institute	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

• DePuy Orthopaedics

Investigators

• Study Director: Tammy O'Dell, EMT, CCRA, CCRC, DePuy

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT00487565
• Other Study ID Numbers: 06005; LCS:PS
• First Posted: Jun 18, 2007
• Last Update Posted: Aug 14, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by DePuy Orthopaedics: Total knee replacement; Total knee arthroplasty; Osteoarthritis; Rheumatoid or other inflammatory arthritis; Post-traumatic or juvenile arthritis
• Additional relevant MeSH terms: Arthritis; Osteoarthritis; Arthritis, Juvenile

Study Results

Participant Flow

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 Detail	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
Arm/Group Description	Total knee arthroplasty with a posterior stabilized implant
Period Title: Overall Study
STARTED	210
COMPLETED	182
NOT COMPLETED	28

Baseline Characteristics

Arm/Group Title	LCS Complete Posterior Stabilized Knee Implant
Arm/Group Description	Total knee arthroplasty with a posterior stabilized implant
Overall Participants	210
Age (participants) [Mean (Standard Deviation) ]
Age	63.8 (9.8) 30.4%
Sex: Female, Male (Count of Participants)
Female	120 57.1%
Male	90 42.9%
Region of Enrollment (participants) [Number]
United States	180 85.7%
Switzerland	30 14.3%

Outcome Measures

1. Primary Outcome

Title	Knee Active Flexion
Description	Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LCS Complete Posterior Stabilized Knee Implant
Arm/Group Description	Total knee arthroplasty with a posterior stabilized implant
Measure Participants	182
Mean (Standard Deviation) [degrees]	119.2 (9.9)

Adverse Events

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
Arm/Group Description	Total knee arthroplasty with a posterior stabilized implant
All Cause Mortality
	LCS Complete Posterior Stabilized Knee Implant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	LCS Complete Posterior Stabilized Knee Implant
	Affected / at Risk (%)	# Events
Total	28/210 (13.3%)
Cardiac disorders
Cardiac	1/210 (0.5%)	1
Gastrointestinal disorders
Gastrointestinal	4/210 (1.9%)	4
Musculoskeletal and connective tissue disorders
Hemarthrosis	2/210 (1%)	2
Musculoskeletal	10/210 (4.8%)	10
Other-Arthrofibrosis	1/210 (0.5%)	1
Other - Dehiscence Arthrotomy	1/210 (0.5%)	1
Other - Distal Screw Failed at the Tuberocitas Osteotomy	1/210 (0.5%)	1
Other - Loose Cement	1/210 (0.5%)	1
Other - Polyethylene Spin Out After Fainting	1/210 (0.5%)	1
Other- Subpatellar Crepitation	1/210 (0.5%)	1
Other - Wound Dehiscence	1/210 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	2/210 (1%)	2
Nervous system disorders
Neurological	3/210 (1.4%)	3
Respiratory, thoracic and mediastinal disorders
Respiratory System	1/210 (0.5%)	1
Other (Not Including Serious) Adverse Events
	LCS Complete Posterior Stabilized Knee Implant
	Affected / at Risk (%)	# Events
Total	11/210 (5.2%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	11/210 (5.2%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.