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Orthopedic Implant
Hip Replacement System for Hip Osteoarthritis ((HRS-P) Trial)
N/A
Recruiting
Led By Thomas Turgeon, MD
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 has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement.
Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between pre-operative and 730 days (24 months)
Awards & highlights
(HRS-P) Trial Summary
This trialwill test a new device for hip replacement surgery to see if it's safe and effective. Outcomes will be measured by patient reports, clinical tests, radiologic and radiostereometric tests.
Who is the study for?
This trial is for individuals aged 65-79 with non-inflammatory degenerative joint diseases like osteoarthritis, needing a hip replacement. They must have a certain level of pre-surgery pain and disability, be able to follow the study's procedures, and not have conditions that could affect their participation or assessment such as autoimmune joint diseases, severe bone deficiencies, or recent other hip surgeries.Check my eligibility
What is being tested?
The HIT Hip Replacement System is being tested in patients undergoing total hip arthroplasty. The study aims to assess how effective and safe this system is by looking at patient feedback, clinical outcomes, X-rays results, and any unexpected events related to the device.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks associated with total hip replacements may include pain at the surgery site, infection risk around the implant area or general health complications from surgery.
(HRS-P) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a hip replacement due to a non-inflammatory joint condition like osteoarthritis.
Select...
My pre-surgery pain and joint function score is 40 or higher.
Select...
I am between 65 and 79 years old.
(HRS-P) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between pre-operative and 730 days (24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between pre-operative and 730 days (24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Harris Hip Score between baseline (pre-operative) and the 730-day post-operative follow-up time point.
Erythrocyte Indices
Secondary outcome measures
Change in Oxford Hip Score between 730-day post-operative and baseline (pre-surgery)
Change in Short Form 36 v2 Physical Component Score (PCS) between 730-days post-operative and baseline (pre-surgery)
(HRS-P) Trial Design
1Treatment groups
Experimental Treatment
Group I: HIT Hip Replacement System (HRS)Experimental Treatment1 Intervention
Single group assignment with historical controls.
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Who is running the clinical trial?
Hip Innovation TechnologyLead Sponsor
1 Previous Clinical Trials
288 Total Patients Enrolled
Branko Kopjar, MD, PhDStudy DirectorNor Consult, LLC
1 Previous Clinical Trials
193 Total Patients Enrolled
Thomas Turgeon, MDPrincipal InvestigatorOrthopaedic Innovation Centre
8 Previous Clinical Trials
281 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a hip replacement due to a non-inflammatory joint condition like osteoarthritis.My hip bones are too weak for implants to attach properly.I had hip surgery in the last year.I have had a serious infection in my joint.You are allergic to any part of the study device.My affected limb is deformed or my hip is significantly different than usual.My pre-surgery pain and joint function score is 40 or higher.I haven't had cancer, except for certain skin cancers or treated cervical cancer, in the last 5 years.I have poor blood flow, muscle loss, or nerve disease in my legs.I am considered a good candidate for a total hip replacement.I am missing some or all of my muscle or ligament structure.You have a condition that would make it difficult for you to assess your own pain or quality of life during the study.I have an autoimmune condition like rheumatoid arthritis or lupus.You have a condition that the doctor believes could affect the success of your hip replacement surgery or your overall health after the surgery.I have a history of bone diseases like Paget's or osteomalacia.I have moderate to severe kidney problems.I am scheduled for hip replacement surgery on the opposite side within a year.I do not have an active infection like hepatitis or AIDS.I am between 65 and 79 years old.
Research Study Groups:
This trial has the following groups:- Group 1: HIT Hip Replacement System (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.
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