Aseptic LooseningMRHSNCT01464645
Post-Market Study of the Modular Revision Hip System
An observational study of Aseptic Loosening and Osteolysis, run by Encore Medical, L.P. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic Loosening, Osteolysis, Traumatic Fracture
- What is being tested?
- Modular Revision Hip System
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751
Orthopaedic Surgery Specialists
Burbank, California, 91505
Orthopedic Associates of Pittsburgh, Inc.
Monroeville, Pennsylvania, 15146
McBride Clinic
Oklahoma City, Oklahoma, 73103
Stanford Medical Center Outpatient Clinic
Redwood City, California, 94063
Syracuse Orthopaedic Specialists
Syracuse, New York, 13214
About this study
Official title: Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS)
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.
Read the 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.
- Being tested
- Modular Revision Hip System
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Revision Hip SystemDevice
Also called MRHS
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary | Post Market Study Receives: Device: Modular Revision Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic LooseningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Michael Levine, M.D., Principal investigator, Orthopedic Associates of Pittsburgh, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464645
- Sponsor's protocol ID
- PS-804
- Acronym
- MRHS
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2011
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS)
- ClinicalTrials.gov ID
- NCT01464645
- Acronym / sponsor ID
- MRHS / PS-804
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Device: Modular Revision Hip SystemPost Market Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modular Revision Hip SystemAlso: MRHSHip 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. | Device | Primary |
Primary outcome
Harris Hip Score Evaluation
Time frame: 2 year
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
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Levine, M.D. principal investigator
Orthopedic Associates of Pittsburgh, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aseptic Loosening and Osteolysis, run by Encore Medical, L.P. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score Evaluation (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018; AzTrials last refreshed its copy on 3 Nov 2026.