Encore Revelation Hip Stem

This study has been completed.
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01514318
First received: December 22, 2011
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip
Complications; Arthroplasty
Device: Revelation Hip Stem (Revelation)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term Follow Up Study of the Revelation™ Hip Stem

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Survivorship of the Device [ Time Frame: 10 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Western Ontario McMaster Arthritis Index (WOMAC) [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514318

Locations
United States, Texas
Westlake Orthopaedics Spine & Sports
Austin, Texas, United States, 78746
Sponsors and Collaborators
Encore Medical, L.P.
DJO Incorporated
Investigators
Principal Investigator: Frosty Moore, M.D. Westlake Orthopaedics Spine & Sports
  More Information

No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01514318     History of Changes
Other Study ID Numbers: PS-805
Study First Received: December 22, 2011
Results First Received: July 18, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014