Knee Arthroplasty Registry

Heekin Orthopedic Research Institute

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: any knee joint arthroplasty device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01132365

05-05-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 7,793 estimated patients

Sex: All

Ages: 21 to 93 years old

Volunteers: No Healthy Volunteers

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.

Trial design

7,793 participants in 1 patient group

knee arthroplasty

Treatment:

Device: any knee joint arthroplasty device