Post-Market Study of the Modular Revision Hip System (MRHS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Encore Medical, L.P.
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01464645
First received: November 2, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Aseptic Loosening
Osteolysis
Traumatic Fracture
Failed Total Hip Implant
Device: Modular Revision Hip System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS)

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

Primary Outcome Measures:
  • Harris Hip Score Evaluation [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Radiologic Failure of Device [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary
Post Market Study
Device: Modular Revision Hip System
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.
Other Name: MRHS

Detailed Description:

The main goal of Revision Total Hip Arthroplasty (THA) is to restore the patient's hip function by repairing the patient's kinematics. However, a revision hip surgery represents a challenge for even the most experienced surgeon. Loss of bone stock, joint stability, infection, fracture, trochanteric non-union, and difficulty in implant or cement removal are all potential issues that a surgeon must consider for each presenting patient. These challenges require hip implant systems to provide an intraoperative flexibility that is not normally required for primary THA. The Lima Modular Revision Hip System uses modular stem and neck components to allow for surgical versatility when selecting leg length, offset and version. The purpose of this study is to examine the short term safety and efficacy of the Modular Revision Hip System (MHRS) using radiologic success and Harris Hip Scores as endpoints. The study will take place at multiple sites across the United States and will include only subjects who meet the indications for use criteria for the Modular Revision Hip system and who are candidates for revision hip replacement surgery. Target enrollment will be 200 subjects with up to 25 subjects at 15 sites across the United States.

  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

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject is younger than 18 years of age (<18) at the time of consent
  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: NCT01464645

Contacts
Contact: Beth L Brakewood, MPH, CIP 512-834-6270 beth.brakewood@djoglobal.com

Locations
United States, California
Orthopaedic Surgery Specialists Terminated
Burbank, California, United States, 91505
Stanford Medical Center Outpatient Clinic Recruiting
Redwood City, California, United States, 94063
Principal Investigator: Stuart Goodman, MD         
United States, Florida
Coastal Orthopedics & Sports Medicine Withdrawn
Bradenton, Florida, United States, 34209
Florida Orthopaedic Institute Withdrawn
Tampa, Florida, United States, 33629
United States, Idaho
St. Alphonsus Medical Group Withdrawn
Boise, Idaho, United States, 83706
United States, New Mexico
New Mexico Orthopedics Withdrawn
Albuquerque, New Mexico, United States, 87106
United States, New York
NYU Hospital for Joint Diseases Withdrawn
New York, New York, United States, 10003
Syracuse Orthopaedic Specialists Terminated
Syracuse, New York, United States, 13214
United States, Ohio
SportsMedicine Grant & Orthopaedic Association Withdrawn
Columbus, Ohio, United States, 43215
United States, Oklahoma
McBride Clinic Terminated
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Orthopedic Associates of Pittsburgh, Inc. Terminated
Monroeville, Pennsylvania, United States, 15146
United States, Texas
Texas Institute for Hip and Knee Surgery Terminated
Austin, Texas, United States, 78751
United States, Wisconsin
Medical College of Wisconsin Withdrawn
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Encore Medical, L.P.
DJO Incorporated
Investigators
Principal Investigator: Michael Levine, M.D. Orthopedic Associates of Pittsburgh, Inc.
  More Information

No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01464645     History of Changes
Other Study ID Numbers: PS-804
Study First Received: November 2, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteolysis
Bone Resorption
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 11, 2014