Improving the postmarket surveillance of total joint arthroplasty devices.

Objective: To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices.

Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system.

Patient expectations regarding total knee arthroplasty: differences among the United States, United Kingdom, and Australia.

Background: Total knee arthroplasty is an effective treatment for severe osteoarthritis of the knee. Our aim was to determine whether patients from the United Kingdom, United States, and Australia have different preoperative expectations regarding total knee arthroplasty and whether these expectations have an impact on outcomes and patient satisfaction.

Methods: Patients from the United Kingdom, the United States, and Australia were recruited into a prospective observational study of primary total knee arthroplasty for the treatment of osteoarthritis.

Patient-reported outcome and survivorship after Kinemax total knee arthroplasty.

Background: We examined the long-term survivorship and patient-reported outcomes at a minimum of ten years following primary total knee arthroplasty. We hypothesized (1) that the survival rate would be at least 90% at ten years; (2) that age, gender, body-mass index, and primary diagnosis would not affect the survival rate; and (3) that the functional status of patients would be comparable with that of an age and gender-matched normal population.

Methods: A total of 407 patients (523 knees) who had had primary total knee arthroplasty between January 1988 and April 1991 were identified.

Predicting the outcome of total knee arthroplasty.

Background: The relief of pain and the restoration of functional activities are the main outcomes of primary total knee arthroplasty for the treatment of osteoarthritis. This paper examines the preoperative predictors of pain and functional outcome at one and two years following total knee arthroplasty.

Methods: Patients were recruited for a prospective observational study of primary total knee arthroplasty for the treatment of osteoarthritis from centers in the United States, the United Kingdom, and Australia.

Validation of a Japanese patient-derived outcome scale for assessing total knee arthroplasty: comparison with Western Ontario and McMaster Universities osteoarthritis index (WOMAC).

We have developed a Japanese self-administered questionnaire based on an English version of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) to measure subjective function and pain status of patients who undergo a total knee arthroplasty procedure. Using multiple international cohorts, the performance of the developed Japanese scale was compared to the results of the WOMAC in the United Kingdom, United States, Canada, and Australia. The developed scale showed a comparable level of internal consistency and construct/criterion validity.

Knee range of motion after total knee arthroplasty: how important is this as an outcome measure?

We investigated the relationship of knee range of motion (ROM) and function in a prospective, observational study of primary total knee arthroplasty (TKA). Preoperative and 12-month data were collected on 684 patients, including knee ROM, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function questionnaire scores, patient satisfaction, and perceived improvement in quality of life (QOL). Only modest correlations were found between knee ROM and WOMAC function (r<0.