Osteoarthritis, Knee
Conditions
Keywords
knee arthroplasty
Brief summary
Objective Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes. Examine the relationship between processes of care, hospital and surgeon associated outcomes. Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients. Analyze and design ancillary studies to address unanswered questions. Disseminate findings through publication in peer-reviewed scientific journals.
Detailed description
Population: All male and non-pregnant females undergoing knee arthroplasty. Study Design: Prospective, consecutive series on an unlimited number of patients. Data Collection Clinic Data: Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results Surgical Data: Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view
Interventions
DEVICEany knee joint arthroplasty device
Cohort consist of all consented patients receiving knee arthroplasty
Sponsors
DePuy Orthopaedics
Stryker Orthopaedics
Restor3D
Heekin Orthopedic Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 93 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is a male or non-pregnant female over the age of 21. 2. Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty 3. Patient has signed and dated an IRB approved consent form. 4. Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions. 5. Patient has failed to respond to conservative treatment modalities.
Exclusion criteria
1. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. 2. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score | 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years |
Countries
United States
Outcome results
None listed