288 Participants Needed

HIT Reverse Hip Replacement System for Osteoarthritis

Recruiting at 5 trial locations
GD
Overseen ByGeorge Diamantoni
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hip Innovation Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new hip replacement device called the HIT Reverse Hip Replacement System. It aims to see if this new device is safe and effective for patients who need a total hip replacement. The device works by replacing damaged parts of the hip with artificial ones to improve movement and reduce pain.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for the HIT Reverse Hip Replacement System and similar hip systems?

The safety data for similar hip systems, such as those using metal-on-XLPE or ceramic-on-XLPE bearings, indicate some concerns. A study on a ceramic liner system showed a high rate of loosening, leading to revisions, and some patients experienced noise like squeaking or clicking. Another review found a low incidence of adverse reactions to metal debris in modular dual-mobility constructs, but there were concerns about metal ion levels and the need for proper implant seating to avoid complications.12345

How is the HIT Reverse Hip Replacement System treatment different from other treatments for osteoarthritis?

The HIT Reverse Hip Replacement System is unique because it uses a reverse design with a femoral cup and acetabular ball, which enhances mechanical stability compared to traditional hip replacements. This novel design aims to reduce the common issue of instability after hip replacement surgery.678910

What data supports the effectiveness of the HIT Reverse Hip Replacement System treatment for osteoarthritis?

The effectiveness of hip replacement surgery, which is similar to the HIT Reverse Hip Replacement System, has been shown to improve pain and hip function in patients with conditions like necrosis of the femoral head. This suggests that similar improvements might be expected for osteoarthritis patients using the HIT system.1112131415

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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 a signed and dated Informed Consent Form (ICF)
I am between 50 and 75 years old.
See 2 more

Exclusion Criteria

Patient has a Body Mass Index (BMI) of 40 or higher
I need both hips replaced or have a hip replacement planned for the other side within 2 years.
I had hip surgery on the opposite side over 2 years ago and still feel pain of at least 2 out of 10.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total hip arthroplasty using either the HIT Reverse Hip Replacement System or a control hip system

Immediate post-surgery
1 visit (in-person)

Post-surgical care and rehabilitation

Standard of care post-surgical care and rehabilitation for both arms

6 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including metal ion levels and radiographic evaluations

10 years
Multiple visits at 1, 2, 3, 4, 5, 7, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination
  • Hip Innovation Technology Reverse Hip Replacement System
Trial Overview 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.
How Is the Trial Designed?
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.

Hip Innovation Technology Reverse Hip Replacement System is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as HIT Reverse HRS for:
  • Total Hip Replacement
🇨🇦
Approved in Canada as HIT Reverse HRS for:
  • Total Hip Replacement
🇪🇺
Approved in European Union as HIT Reverse HRS for:
  • Total Hip Replacement

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hip Innovation Technology

Lead Sponsor

Trials
2
Recruited
390+

Published Research Related to This Trial

In a study of 86 patients with necrosis of the femoral head, modified artificial hip replacement surgery showed a significantly higher treatment efficacy (93.02%) compared to conventional hip replacement (79.07%).
Patients who underwent the modified procedure experienced greater reductions in pain (VAS scores) and improvements in hip function (Harris hip scores) and motor function (Fugl-Meyer scores), while also having a lower incidence of adverse reactions (6.98% vs. 16.28%).
Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis.Li, F., Zhu, L., Geng, Y., et al.[2021]
The Spanish version of the Hip Outcome Score (HOS) has been successfully translated and validated for use in patients undergoing hip arthroscopy, demonstrating high reliability with an intraclass correlation coefficient of 0.95 for activities of daily living (ADL) and 0.94 for sports.
This validated tool shows strong internal consistency and sensitivity to change, making it effective for assessing treatment outcomes in both Spanish- and English-speaking patients, thus facilitating cross-cultural research in hip pathology.
Validation of the Spanish version of the Hip Outcome Score: a multicenter study.Seijas, R., Sallent, A., Ruiz-Ibán, MA., et al.[2021]
A study involving 399 patients showed that the modified Harris hip score (MHHS) and Oxford hip score (OHS) are effective tools for evaluating functional outcomes after various types of hip surgeries, including primary total hip arthroplasty (THA) and hip hemiarthroplasty (HA).
There was a very strong correlation between the Harris hip score (HHS) and both MHHS and OHS across different patient groups, indicating that these scores can reliably assess hip function post-surgery.
Correlation between Harris, modified Harris hip, and Oxford hip scores of patients who underwent hip arthroplasty and hemiarthroplasty following hip fracture.Kızkapan, TB., Mısır, A., Eken, G., et al.[2023]

Citations

Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis. [2021]
Validation of the Spanish version of the Hip Outcome Score: a multicenter study. [2021]
Correlation between Harris, modified Harris hip, and Oxford hip scores of patients who underwent hip arthroplasty and hemiarthroplasty following hip fracture. [2023]
Validation of the Brazilian version of the Hip Outcome Score (HOS) questionnaire. [2019]
Reproducibility, validity, and responsiveness of the hip outcome score in patients with end-stage hip osteoarthritis. [2019]
Personalized Hip Joint Replacement with Large Diameter Head: Current Concepts. [2022]
Poor outcome of a spherical pressfit cup with a modern ceramic liner: a prospective cohort study of 181 cups. [2017]
Short Stem for Total Hip Arthroplasty (THA) - Overview, Patient Selection and Perspectives by Using the Metha® Hip Stem System. [2022]
Adverse reaction to metal debris due to fretting corrosion between the acetabular components of modular dual-mobility constructs in total hip replacement: a systematic review and meta-analysis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
The Role of Dual-mobility Cups in Total Hip Arthroplasty. [2015]
Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years. [2023]
Influence of the femoral head size on early postoperative gait restoration after total hip arthroplasty. [2009]
13.Czech Republicpubmed.ncbi.nlm.nih.gov
Tribological considerations for a new hip system. [2016]
[Total hip replacement after Legg-Calvé-Perthes disease]. [2016]
15.United Statespubmed.ncbi.nlm.nih.gov
Use of bearings with integrated ceramic insert in cementless total hip arthroplasty – a preliminary report. [2019]
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