Encore Revelation Hip Stem

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514318
• Other study ID #: PS-805
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: October 31, 2012
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications; Arthroplasty
• Osteoarthritis, Hip

Intervention

Device:
• Revelation Hip Stem (Revelation)
Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.

Locations

Country	Name	City	State
United States	Westlake Orthopaedics Spine & Sports	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Encore Medical, L.P.	DJO Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No