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Hip Replacement System
HIT Reverse Hip Replacement System for Osteoarthritis
N/A
Recruiting
Research Sponsored by Hip Innovation Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment
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 requiring unilateral primary THA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 year
Awards & highlights
Study Summary
This trialwill measure if a new hip replacement system is safe & effective compared to existing ones.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to implant materials such as pain at the site, inflammation around the joint, allergic responses if sensitive to materials used in implants (titanium/XLPE), and complications from surgery like infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 75 years old.
Select...
I need a hip replacement due to joint damage or disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of revision at the 2-year follow-up visit
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
OHS of 36 or more at the 2-year follow-up visit
+1 moreSecondary outcome measures
Change in HHS compared to baseline at all follow-up visits.
Change in OHS compared to baseline at all follow-up visits.
Other outcome measures
Exploratory Endpoints: Device survivorship
Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) at all follow-up visits.
Exploratory Endpoints: Metal ion level assessment of titanium, cobalt, and chromium.
+3 moreTrial Design
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.
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Who is running the clinical trial?
Hip Innovation TechnologyLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need both hips replaced or have a hip replacement planned for the other side within 2 years.I am between 50 and 75 years old.I had hip surgery on the opposite side over 2 years ago and still feel pain of at least 2 out of 10.I do not have an active infection like hepatitis or AIDS.You have an allergy to titanium or XLPE materials.You have a condition that would make it difficult for you to accurately report your pain, ability to function, or quality of life during the study.I have Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.I am medically cleared for surgery and have no untreated conditions that increase surgical risk.I need or am scheduled for knee replacement surgery within the next 2 years.My hip bones are too weak to support an implant.My affected limb is deformed or my hip is significantly different than usual.You have a condition in your legs that affects blood flow, muscle strength, or nerves, as determined by the doctor.I have missing muscles or ligaments.You are a competitive or professional athlete.I haven't had cancer, except for certain skin cancers or treated cervical cancer over a year ago.I need a hip replacement due to joint damage or disease.You cannot be part of any other research study that is not directly related to the care you will receive before or after this study.I have moderate to severe kidney problems.I had surgery on my other hip within the last 2 years.I have had a joint infection in the affected joint.I have an inflammatory joint disease such as rheumatoid arthritis or lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Experimental Arm - HIT Reverse HRS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to enlist in this research presently?
"Affirmative. According to information found on clinicaltrials.gov, this medical study went live on July 15th 2022 and was updated most recently on January 16th 2023. The trial is enrolling 288 patients at a single site."
Answered by AI
How many participants are involved in this scientific investigation?
"Affirmative. According to information hosted on clinicaltrials.gov, this research trial is actively recruiting participants. The study was first advertised on July 15th 2022 and the most recent update occured on January 16th 2023 with a goal of 288 volunteers from one medical site."
Answered by AI
Is the age range for participants in this study limited to those over 45 years of age?
"This clinical study necessitates that participants are within the 50 to 75 age bracket. Compared, there are 53 trials catered towards those under 18 and 699 for seniors aged 65 and above."
Answered by AI
Am I able to join this research study?
"This trial is looking for 288 individuals aged 50-75 with a diagnosis of osteoarthritis. Additionally, interested participants must satisfy the following conditions: have indication for primary total hip arthroplasy due to noninflammatory degenerative joint disease or any of its associated symptoms (e.g., avascular necrosis, posttraumatic arthritis, slipped capital epiphysis), be medically cleared prior to surgery and free from diseases that pose excessive operative risk, agree to attend all follow up visits at the investigational site and complete study procedures/questionnaires as required; provide signed consent form affirming their participation in this clinical study."
Answered by AI
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