Encore Revelation Hip Stem
|ClinicalTrials.gov Identifier: NCT01514318|
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Hip Complications; Arthroplasty||Device: Revelation Hip Stem (Revelation)|
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||A Long-term Follow Up Study of the Revelation™ Hip Stem|
|Study Start Date :||February 2012|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
Device: Revelation Hip Stem (Revelation)
Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.
- Survivorship of the Device [ Time Frame: 10 year ]The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.
- Western Ontario McMaster Arthritis Index (WOMAC) [ Time Frame: 10 year ]Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
- Harris Hip Score [ Time Frame: 10 year ]A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514318
|United States, Texas|
|Westlake Orthopaedics Spine & Sports|
|Austin, Texas, United States, 78746|
|Principal Investigator:||Frosty Moore, M.D.||Westlake Orthopaedics Spine & Sports|