Post-Market Study of the Modular Revision Hip System

NCT ID: NCT01464645

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary

Post Market Study

Modular Revision Hip System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MRHS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DJO Incorporated

INDUSTRY

Sponsor Role: collaborator

Encore Medical, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Levine, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Associates of Pittsburgh, Inc.

Locations

Orthopaedic Surgery Specialists

Burbank, California, United States

Stanford Medical Center Outpatient Clinic

Redwood City, California, United States

Syracuse Orthopaedic Specialists

Syracuse, New York, United States

McBride Clinic

Oklahoma City, Oklahoma, United States

Orthopedic Associates of Pittsburgh, Inc.

Monroeville, Pennsylvania, United States

Texas Institute for Hip and Knee Surgery

Austin, Texas, United States

Countries

United States

Other Identifiers

PS-804

Identifier Type: -

Identifier Source: org_study_id