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New treatment option for Osteoarthritis of Hip
Official title Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT02836262
What this study is testing
- What it's testing
- To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and radiostereometric outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 79
You may be able to join if
- Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis...
- Age between 65 and 79 years (inclusive) at the time of enrollment.
- Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.
- Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)
- Signed and dated informed consent document.
You likely can't join if
- Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;
- Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;
- Patient has a known allergy to any component of the study device;
- Patient has a history of active sepsis in the joint;
- Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible;
- Patient has total or partial absence of the muscular or ligamentous apparatus;
See the full eligibility criteria
- 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...
- Age between 65 and 79 years (inclusive) at the time of enrollment.
- Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.
- Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)
- Signed and dated informed consent document.
- 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 had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;
- Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;
- Patient has a known allergy to any component of the study device;
- Patient has a history of active sepsis in the joint;
- Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are 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 discretion);
- 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 five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively...
- Patient has any condition which may, in the opinion of the Investigator, interfere with the total hip replacement survival or patient outcomes (e.g. Paget's disease, Charcot's disease);
- Patient has rheumatoid arthritis or other autoimmune condition that affect joints (e.g. Lupus Arthritis);
- Patient has any condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion);
- Body Mass Index (BMI) of 40 or more;
- Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the site of intended surgery;
- Patient is currently participating in any investigational study not related to this study's pre-operative or post-operative care;
- Patient has any other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the Investigator, which would make the patient inappropriate for entry...
- Patient has a history of metabolic bone disease (e.g. Paget's disease or osteomalacia);
- Patient is currently pregnant or is planning to become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Winnipeg, Manitoba, Canada
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, 65 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winnipeg, Manitoba, Canada. 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.