Actively Recruiting
Safety and Effectiveness of the HIT Reverse HRS
Led by Hip Innovation Technology · Updated on 2026-05-11
288
Participants Needed
6
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
CONDITIONS
Official Title
Safety and Effectiveness of the HIT Reverse HRS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requires primary total hip arthroplasty due to degenerative joint disease or related conditions such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, pelvic fracture, or diastrophic variant.
- Patient is between 50 and 75 years old at enrollment.
- Patient has medical clearance and is free from or treated for medical conditions that pose excessive surgical risk.
- Patient has signed an informed consent form.
- Patient is willing and able to attend follow-up visits and complete study procedures and questionnaires.
You will not qualify if you...
- Patient has had total hip replacement, hemi-arthroplasty, or fusion in the opposite hip within the last 24 months.
- Patient had such surgery in the opposite hip more than 24 months ago but has moderate or higher pain (rating 2 or more on a 0-10 scale) in that hip.
- Patient requires bilateral hip replacement or plans to have the opposite hip replaced within 24 months.
- Patient requires or plans to have knee replacement surgery within 24 months.
- Patient has known allergy to titanium or highly cross-linked polyethylene (XLPE).
- Patient has metal sensitivity to cobalt chromium.
- Patient has history of septic arthritis in the affected hip.
- Patient has insufficient bone stock for proper implant anchorage.
- Patient has total or partial absence of muscles or ligaments around the hip.
- Patient has moderate to severe kidney problems.
- Patient has vascular problems, muscle wasting, or neuromuscular disease in either leg.
- Patient has deformity or significant anatomic differences in the affected hip or limb.
- Patient has active cancer or invasive cancer history within 5 years (with some exceptions).
- Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
- Patient has inflammatory joint disease including rheumatoid arthritis or lupus.
- Patient has conditions interfering with self-assessment of pain, function, or quality of life.
- Patient has a body mass index (BMI) of 40 or higher.
- Patient has an active infection such as hepatitis or AIDS.
- Patient is currently participating in another investigational study not related to this study's care.
- Patient is pregnant or planning pregnancy during the study.
- Patient is a competitive or professional athlete.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Miami Institute for Joint Reconstruction
Miami, Florida, United States, 33186
Actively Recruiting
2
Advent Health Hospital, Carrollwood
Tampa, Florida, United States, 33614
Actively Recruiting
3
Tampa General Health / Florida Orthopedic Institute
Tampa, Florida, United States, 33615
Actively Recruiting
4
LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States, 21215
Terminated
5
Division of Orthopaedic Surgery
Somers Point, New Jersey, United States, 08244
Actively Recruiting
6
JIS Orthopedics
New Albany, Ohio, United States, 43054
Actively Recruiting
Research Team
G
George Diamantoni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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