Encore Revelation Hip Stem

A Long-term Follow Up Study of the Revelation™ Hip Stem

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Complications; Arthroplasty
• Intervention / Treatment: Device: Revelation Hip Stem (Revelation)

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Orthopaedics Spine & Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include only subjects who received the Revelation Hip Stem prior to 2002 and who voluntarily consent to take part in this study.

Description

Inclusion Criteria:

• Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
• Surgery must have been a primary total hip replacement
• Subject must have received only one primary hip replacement per hospitalization
• Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
• Subject must be willing and able to sign the informed consent document

Exclusion Criteria:

• Subject must not have had any previous hip implants (hemi or total joint)
• Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject is a prisoner
• Subject is pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Revelation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of the Device	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.	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario McMaster Arthritis Index (WOMAC)	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.	10 year
Harris Hip Score	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.	10 year

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Collaborators: DJO Incorporated
• Investigators: Principal Investigator: Frosty Moore, M.D., Westlake Orthopaedics Spine & Sports

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: PS-805