Juvenile Arthritis, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Total knee replacement, Total knee arthroplasty, Osteoarthritis, Rheumatoid or other inflammatory arthritis, Post-traumatic or juvenile arthritis
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
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.
Interventions
DEVICETotal knee arthroplasty
Total knee arthroplasty using a posterior stabilized implant
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Active Flexion | 12 month | Active flexion is measured by how much a patient can bend their knee on their own, without assistance. |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| LCS Complete Posterior Stabilized Knee Implant Total knee arthroplasty with a posterior stabilized implant | 210 |
| Total | 210 |
Baseline characteristics
| Characteristic | LCS Complete Posterior Stabilized Knee Implant |
|---|---|
| Age Continuous Age | 63.8 participants STANDARD_DEVIATION 9.8 |
| Region of Enrollment Switzerland | 30 participants |
| Region of Enrollment United States | 180 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 210 |
| serious Total, serious adverse events | 28 / 210 |
Outcome results
Primary
Knee Active Flexion
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCS Complete Posterior Stabilized Knee Implant | Knee Active Flexion | 119.2 degrees | Standard Deviation 9.9 |