HIT Reverse Hip Replacement System for Osteoarthritis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hip Innovation Technology
Disqualifiers: Renal insufficiency, Inflammatory DJD, Active infection, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new hip replacement device called the HIT Reverse Hip Replacement System. It aims to see if this new device is safe and effective for patients who need a total hip replacement. The device works by replacing damaged parts of the hip with artificial ones to improve movement and reduce pain.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the HIT Reverse Hip Replacement System treatment for osteoarthritis?
The effectiveness of hip replacement surgery, which is similar to the HIT Reverse Hip Replacement System, has been shown to improve pain and hip function in patients with conditions like necrosis of the femoral head. This suggests that similar improvements might be expected for osteoarthritis patients using the HIT system.
12345What safety data exists for the HIT Reverse Hip Replacement System and similar hip systems?
The safety data for similar hip systems, such as those using metal-on-XLPE or ceramic-on-XLPE bearings, indicate some concerns. A study on a ceramic liner system showed a high rate of loosening, leading to revisions, and some patients experienced noise like squeaking or clicking. Another review found a low incidence of adverse reactions to metal debris in modular dual-mobility constructs, but there were concerns about metal ion levels and the need for proper implant seating to avoid complications.
678910How is the HIT Reverse Hip Replacement System treatment different from other treatments for osteoarthritis?
The HIT Reverse Hip Replacement System is unique because it uses a reverse design with a femoral cup and acetabular ball, which enhances mechanical stability compared to traditional hip replacements. This novel design aims to reduce the common issue of instability after hip replacement surgery.
1112131415Eligibility Criteria
This trial is for individuals aged 50-75 needing a hip replacement due to conditions like osteoarthritis or avascular necrosis. Candidates must be able to attend follow-ups and have no excessive operative risks, allergies to titanium/XLPE, severe renal insufficiency, neuromuscular diseases, BMI over 40, active infections or certain cancers within the last 5 years.Inclusion Criteria
Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
Patient has a signed and dated Informed Consent Form (ICF)
I am between 50 and 75 years old.
+2 more
Exclusion Criteria
Patient has a Body Mass Index (BMI) of 40 or higher
I need both hips replaced or have a hip replacement planned for the other side within 2 years.
I had hip surgery on the opposite side over 2 years ago and still feel pain of at least 2 out of 10.
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo primary total hip arthroplasty using either the HIT Reverse Hip Replacement System or a control hip system
Immediate post-surgery
1 visit (in-person)
Post-surgical care and rehabilitation
Standard of care post-surgical care and rehabilitation for both arms
6 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness, including metal ion levels and radiographic evaluations
10 years
Multiple visits at 1, 2, 3, 4, 5, 7, and 10 years
Participant Groups
The study tests the safety and effectiveness of the HIT Reverse Hip Replacement System compared to existing hip systems with metal-on-XLPE or ceramic-on-XLPE bearings in patients undergoing total hip replacement.
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm - HIT Reverse HRSExperimental Treatment1 Intervention
Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
Group II: Control ArmActive Control1 Intervention
Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination.
Hip Innovation Technology Reverse Hip Replacement System is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as HIT Reverse HRS for:
- Total Hip Replacement
🇨🇦 Approved in Canada as HIT Reverse HRS for:
- Total Hip Replacement
🇪🇺 Approved in European Union as HIT Reverse HRS for:
- Total Hip Replacement
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Division of Orthopaedic SurgerySomers Point, NJ
JIS OrthopedicsNew Albany, OH
Loading ...
Who Is Running the Clinical Trial?
Hip Innovation TechnologyLead Sponsor
References
Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis. [2021]To study the effect of hip replacement surgery on the clinical treatment efficacy, VAS score and Harris hip score of patients with necrosis of the femoral head (NFH). A total of 86 patients with NFH who were treated in our hospital from January 2016 to January 2019 were selected as the research subjects, and were divided into the control group (n = 43, conventional artificial hip replacement) and the observation group (n = 43, modified version of artificial hip replacement) according to a random number table method. The treatment efficacy, pain, hip function, motor function and adverse reactions of the two groups were compared.
Validation of the Spanish version of the Hip Outcome Score: a multicenter study. [2021]The Hip Outcome Score (HOS) is a self-reported questionnaire evaluating the outcomes of treatment interventions for hip pathologies, divided in 19 items of activities of daily life (ADL) and 9 sports' items. The aim of the present study is to translate and validate HOS into Spanish.
Correlation between Harris, modified Harris hip, and Oxford hip scores of patients who underwent hip arthroplasty and hemiarthroplasty following hip fracture. [2023]Harris hip score (HHS), modified HHS (MHHS), and Oxford hip score (OHS) were designed to determine the functional outcomes after primary total hip arthroplasty (THA). The aim of this study was to evaluate the correlation between MHHS, HHS, and OHS in different populations of arthroplasty such as primary THA, revision THA, THA for Crowe Type IV developmental dysplasia of the hip (DDH), and hip hemiarthroplasty (HA).
Validation of the Brazilian version of the Hip Outcome Score (HOS) questionnaire. [2019]The Hip Outcome Score (HOS) was developed to evaluate physically active patients with hip disease but without severe degenerative change. A translation and cultural adaptation into Brazilian Portuguese was previously conducted. The aim of this study was to validate the Brazilian version of the HOS (HOS-Brazil) among a group of physically active patients with a diagnosis of femoroacetabular impingement (FAI) or greater trochanteric pain syndrome (GTPS).
Reproducibility, validity, and responsiveness of the hip outcome score in patients with end-stage hip osteoarthritis. [2019]To evaluate reproducibility, validity, and responsiveness of the Hip Outcome Score (HOS) in patients with end-stage hip osteoarthritis.
Personalized Hip Joint Replacement with Large Diameter Head: Current Concepts. [2022]Hip arthroplasty is a common procedure in elective orthopaedic surgery that has excellent outcomes. Hip replacement surgery aims to create a "forgotten" joint, i.e., a pain-free joint akin to a native articulation. To achieve such goals, hip arthroplasty must be personalised. This is achieved by restoring: the centre of rotation of the native hip; leg length equality; femoral offset; femoral orientation; soft tissue tension; joint stability with an unrestricted hip range of motion; and having appropriate stress transfer to the bone. In addition, the whole pathway should provide an uneventful and swift postoperative recovery and lifetime implant survivorship with unrestricted activities. At our institution, the preferred option is a personalized total hip arthroplasty (THA) with a large diameter head (LDH) using either monobloc or dual-mobility configuration for the acetabular component. LDH THA offers an impingement-free range of motion and a reduced risk of dislocation. The larger head-neck offset allows for a supraphysiologic range of motion (ROM). This can compensate for a patient's abnormal spinopelvic mobility and surgical imprecision. Additionally, LDH bearing with a small clearance exerts a high suction force, which provides greater hip micro-stability. With appropriate biomechanical reconstruction, LDH THA can restore normal gait parameters. This results in unrestricted activities and higher patient satisfaction scores. We use LDH ceramic on ceramic for our patients with a life expectancy of more than 20 years and use LDH dual mobility bearings for all others.
Poor outcome of a spherical pressfit cup with a modern ceramic liner: a prospective cohort study of 181 cups. [2017]A spherical pressfit cup with a new ceramic liner was introduced in a clinical trial in order to improve range of motion and reduce wear induced problems. The early clinical and radiological outcome was assessed.In a prospective cohort study 181 hips received a seleXys TH+ cup (Mathys, Bettlach, Switzerland) in combination with a third generation ceramic liner (ceramys, Mathys, Bettlach, Switzerland). The Harris Hip Score (HHS), pain (VAS) and range of motion (ROM) were recorded, cup migration and inclination were measured. Experience of any noise was documented.Fourteen hips were radiologically loose, seven of them were revised. Two-year survival of the cup was 92% with radiological loosening as the endpoint. There was no correlation between head size and ROM, no patient had a dislocation. There were no ceramic fractures. Two patients experienced squeaking and three clicking at final follow-up.Reasons for loosening might have been multifactorial but the rate of failure was unacceptably high. The use of large heads did not improve the ROM and development of noise could not be prevented with the modern ceramic. We abandoned the use of this implant system.
Short Stem for Total Hip Arthroplasty (THA) - Overview, Patient Selection and Perspectives by Using the Metha® Hip Stem System. [2022]Short stem hip replacement has not only gained attention but also significance over the past decades. However, there still remains uncertainty regarding the correct indications for these stems. Even companies, producing implants, have varying recommendations that are more likely based on a well-meant advice than on statistically evaluated data. Thus, it is important to evaluate the advantages and disadvantages of a short stem prosthesis. The goal of this paper is to reveal some of the existing uncertainty in this field, by analyzing the Metha® short hip stem system. This paper does not only focus on general aspects but also discusses some more specific problems, such as avascular necrosis and post-rheumatic diseases, as well as hip dysplasia and coxarthrosis. The aim is also to convey the opportunity to indicate this type of implant for elderly and obese patients as well as for femoral misalignments following post-Perthes disease, post-traumatic deformities or other malpositions of the hip.
Adverse reaction to metal debris due to fretting corrosion between the acetabular components of modular dual-mobility constructs in total hip replacement: a systematic review and meta-analysis. [2021]Modular dual-mobility (MDM) constructs can be used to reduce dislocation rates after total hip replacement (THR). However, there are concerns about adverse reaction to metal debris (ARMD) as a result of fretting corrosion between the metal liner and shell. This systematic review reports outcomes following THR using MDM components. It was registered with PROSPERO and conducted in line with Cochrane and PRISMA recommendations.Sixteen articles were included overall, with meta-analysis performed on relevant subsets using a random intercept logistic regression model. Estimated median incidence of ARMD requiring revision surgery within study follow-up period was 0.3% (95% CI 0.1 - 1.8%, from 11 cohort studies containing 1312 cases).Serum metal ion levels were mildly raised in 7.9% of cases, and significantly raised in 1.8%, but there was no correlation with worse clinical hip function scores within studies. Dislocation rate was 0.8%. Revision rate was 3.3%.There are mixed reports of wear on the backside of the metal liner from the acetabular shell and screw heads. Both implant design and component malseating are implicated, but currently it is unclear to what extent each factor is responsible.Studies were poor quality with high risk of confounding, especially from trunnion corrosion. We have made recommendations for further work. In the meantime, surgeons should be aware of the potential risk of ARMD when considering using an MDM prosthesis, and, if selecting one, must ensure proper seating of the liner and screws intraoperatively. Cite this article: EFORT Open Rev 2021;6:343-353. DOI: 10.1302/2058-5241.6.200146.
The Role of Dual-mobility Cups in Total Hip Arthroplasty. [2015]It is often challenging to address instability risks when dealing with complex primary total hip arthroplasty and revision hip surgery. The implant-related options available to surgeons to deal with the risks of instability include femoral head size, femoral neck length/offset, component orientation, and the use of constrained articulations. Dual-mobility articulations have long been used in Europe in the setting of a potential or proven unstable hip; this type of articulation is now available in North America after regulatory approval. However, a dual-mobility articulation has its own unique advantages and disadvantages. Before choosing this implant option, the arthroplasty surgeon needs to be fully informed of the design concept, the surgical technique, the advantages, the disadvantages, and the literature surrounding the use of a dual-mobility articulation.
Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years. [2023]Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design.
Influence of the femoral head size on early postoperative gait restoration after total hip arthroplasty. [2009]We investigated the effects of using large-diameter femoral heads in total hip prostheses on early postoperative gait restoration in patients undergoing total hip arthroplasty (THA).
Tribological considerations for a new hip system. [2016]This paper was initiated to evaluate a new total hip system based on cementless fixation and focusing options for different articulations within a single hip system.
[Total hip replacement after Legg-Calvé-Perthes disease]. [2016]Total hip replacement (THR) is at present an accepted treatment in patients with severe osteoarthritis of the hip after Perthes disease. The aim of this paper is to evaluate the results of THR in patients suffering from secondary osteoarthritis, operated from 1990 to 2000 in the Orthopaedic and Traumatologic Department of Poznan University of Medical Sciences.
Use of bearings with integrated ceramic insert in cementless total hip arthroplasty – a preliminary report. [2019]Ceramic-on-ceramic articulation presents advancement in the development modern of hip prostheses. It is particularly important for young patients, in whom complications related with polyethylene damages and metalosis pose a serious clinical problem due to the long period of implant functioning. The aim of this study was to assess the effect of total cementless hip replacement using an implant with a ceramic insert embedded in a metal cup and large prosthetic head constituting a ceramic-on-ceramic system in patients with hip osteoarthritis.