Encore Revelation Hip Stem

NCT01514318 | Completed Results

• 1 other identifier: PS-805
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Hip; Complications; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Western Ontario McMaster Arthritis Index (WOMAC)

  10 year

• Harris Hip Score

  10 year

Study Arms (1)

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)

Interventions

Revelation Hip Stem (Revelation) DEVICE

Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.

Revelation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Encore Medical, L.P.: lead
• DJO Incorporated: collaborator

Study Sites (1)

Westlake Orthopaedics Spine & Sports

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Small patient population to choose from and difficulty in locating people who have not been seen by the doctor in almost 10 years.

Results Point of Contact

• Title: Dr. Jane M. Jacob
• Organization: DJO Surgical

jane.jacob@djoglobal.com

512-834-6323

Study Officials

• Frosty Moore, M.D.

  Westlake Orthopaedics Spine & Sports

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 23, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 30, 2012
• Results First Posted: November 30, 2012

Record last verified: 2012-10

Locations

US (1)