Post-Market Study of the Modular Revision Hip System

Osteolysis Clinical Trial

— MRHS  

Official title:

Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464645
• Other study ID #: PS-804
• Status: Terminated
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Institute for Hip and Knee Surgery	Austin	Texas
United States	Orthopaedic Surgery Specialists	Burbank	California
United States	Orthopedic Associates of Pittsburgh, Inc.	Monroeville	Pennsylvania
United States	McBride Clinic	Oklahoma City	Oklahoma
United States	Stanford Medical Center Outpatient Clinic	Redwood City	California
United States	Syracuse Orthopaedic Specialists	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Encore Medical, L.P.	DJO Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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