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Tests treatment safety and results for Degenerative Joint Disease
Official title Safety and Effectiveness of the HIT Reverse HRS
ClinicalTrials.gov ID: NCT05357378
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis...
- Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
- Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
- Patient has a signed and dated Informed Consent Form (ICF).
- Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and...
You likely can't join if
- Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
- Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific...
- Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
- Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
- Patient has a known allergy to titanium and/or XLPE.
- Patient has known metal sensitivities to cobalt chromium (CoCr).
See the full eligibility criteria
- Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant...
- Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
- Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
- Patient has a signed and dated Informed Consent Form (ICF).
- 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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
- Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
- Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
- Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
- Patient has a known allergy to titanium and/or XLPE.
- Patient has known metal sensitivities to cobalt chromium (CoCr).
- Patient has a history of septic arthritis in the index joint.
- Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is unlikely or impossible.
- Patient has total or partial absence of the muscular or ligamentous apparatus.
- Patient has known moderate to severe renal insufficiency.
- Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's judgment).
- Patient has a deformity of the affected limb or significant anatomic variance of the affected hip.
- Patient has an active malignancy or history of invasive malignancy within the last 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients...
- Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
- Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic...
- Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).
- Patient has a Body Mass Index (BMI) of 40 or higher.
- Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.
- Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care.
- Patient is currently pregnant or is planning to become pregnant during the study.
- Patient is a competitive or professional athlete.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Somers Point, New Jersey, United States
- New Albany, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Somers Point, New Jersey, United States; New Albany, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.