Post-Market Study of the Modular Revision Hip System

NCT01464645 | Terminated

• 1 other identifier: PS-804
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.

Conditions

Aseptic Loosening; Osteolysis; Traumatic Fracture; Failed Total Hip Implant

Outcome Measures

Primary Outcomes (2)

• Harris Hip Score Evaluation

  The Harris Hip Score was developed to evaluate hip function in patients with traumatic disorders of the hip, but it is now commonly used to follow patients after surgery for a degenerative disorder of the hip (Harris et al., 1969). The score is broken down into 4 areas (pain, function, deformity and range of motion), with the best possible score being 100. 44 points are allotted for pain, 47 for mobility/function, 5 for range of motion and 4 for absence of deformity. Grading for the Harris Hip Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (\<70).

  2 year

• Number of Participants With Radiologic Failure of Device

  Radiographic failure is defined as a complete radiolucent line \> 2mm wide at the Prosthesis/Bone Interface or a \>3 Degree Migration varus/valgus or \>3 mm Subsidence of the component.

  2 year

Study Arms (1)

Primary

Post Market Study

Device: Modular Revision Hip System

Interventions

Modular Revision Hip System DEVICE

Hip System that is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

Also known as: MRHS

Primary

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

Eligible subjects will be at least 18 years of age at the time of consent and meet the inclusion criteria for a total hip revision arthroplasty due to poor bone stock, or due to deficiencies of the femoral head, neck or portions of the proximal femur.

You may qualify if:

• Subject must be a candidate for revision hip arthroplasty
• Subject must have either poor bone stock or deficiencies of the femoral head, neck or portions of the proximal femur
• Subject's hip joint must be anatomically and functionally suited to receive the hip implant
• Subject must have a body mass index of 40.00 or less (BMI) ≤ 40.00 at time of consent
• Subject must be willing and able to sign the informed consent and follow study procedures
• Subject must be 18 years of age or older (≥ 18) at the time of consent
• Subject must be willing to return for all study visits
• Subject (female) must not be pregnant at time of surgery

You may not qualify if:

• Subject must not be receiving a primary hip replacement
• Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (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 has a condition that places excessive demand on the implant including high levels of physical activity (i.e. competitive sports, heavy physical labor)
• Subject has a BMI \>40.00
• Subject is skeletally immature
• Subject has osteomyelitis
• Subject has loss of ligamentous structures
• Subject is a prisoner
• Subject is pregnant
• Subject has an active infection or sepsis at time of surgery
• Subject has a history of alcoholism or other addictions (current)
• Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
• Subject has known materials sensitivity (to metals)
• Subject has a physical condition that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant
• Subject is unwilling to modify post-operative physical activities

Sponsors & Collaborators

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

Study Sites (6)

Orthopaedic Surgery Specialists

Burbank, California, 91505, United States

Location

Stanford Medical Center Outpatient Clinic

Redwood City, California, 94063, United States

Location

Syracuse Orthopaedic Specialists

Syracuse, New York, 13214, United States

Location

McBride Clinic

Oklahoma City, Oklahoma, 73103, United States

Location

Orthopedic Associates of Pittsburgh, Inc.

Monroeville, Pennsylvania, 15146, United States

Location

Texas Institute for Hip and Knee Surgery

Austin, Texas, 78751, United States

Location

MeSH Terms

Conditions

Osteolysis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael Levine, M.D.

  Orthopedic Associates of Pittsburgh, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 3, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 10, 2018

Record last verified: 2017-02

Locations

US (6)