What side effects are associated with this type of intervention?

The most common treatment for severe osteoarthritis, particularly in the hip, is total hip replacement surgery. Known side effects of this surgical intervention include infection, blood clots, dislocation of the hip joint, wear and tear of the prosthetic components, and in rare cases, nerve damage. Additionally, there are risks associated with anesthesia and the potential for a need for revision surgery if the implant fails or wears out over time.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, including surgical implantation of hip replacement devices, such as the HIT Reverse Hip Replacement System, which aims to restore hip function and alleviate pain. These devices are designed to replace the damaged hip joint with prosthetic components, improving mobility and reducing discomfort. While specific drugs related to these surgical treatments are not detailed in the provided context, nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen and ibuprofen are commonly used for managing osteoarthritis symptoms.

What other types of research exist?

Promising alternatives to the HIT Reverse Hip Replacement System for osteoarthritis patients include: 1) Reverse hybrid total hip arthroplasty, which uses a cemented cup and an uncemented stem, showing good clinical outcomes and survival rates. 2) Cemented Lubinus and Furlog total hip endoprosthesis, which has demonstrated satisfactory long-term survival and function. 3) Vitamin E-incorporated polyethylene cups in reversed hybrid total hip arthroplasty, designed to improve wear resistance, bone density, and functional outcomes.

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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

Must not have

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 has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 year

Awards & highlights

Summary

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.

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.

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.

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 below

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I am between 50 and 75 years old.

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I need a hip replacement due to joint damage or disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection like hepatitis or AIDS.

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I have Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.

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My hip bones are too weak to support an implant.

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My affected limb is deformed or my hip is significantly different than usual.

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I have missing muscles or ligaments.

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I have moderate to severe kidney problems.

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I have had a joint infection in the affected joint.

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I have an inflammatory joint disease such as rheumatoid arthritis or lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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Secondary study objectives

Change in HHS compared to baseline at all follow-up visits.

Change in OHS compared to baseline at all follow-up visits.

Other study objectives

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.

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Trial 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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include non-surgical options like analgesics (e.g., acetaminophen) and NSAIDs (e.g., ibuprofen, naproxen) that manage pain and inflammation but do not alter disease progression. Surgical treatments, such as the HIT Reverse Hip Replacement System, involve implanting a prosthetic device to replace the damaged hip joint, aiming to restore function, alleviate pain, and improve mobility. Understanding these mechanisms helps OA patients make informed decisions about balancing immediate pain relief with long-term functional outcomes.

Progress in the treatment of knee osteoarthritis with high tibial osteotomy: a systematic review.[The experience of the using Tolperisone in a complex conservative therapy of an osteoarthrosis of a hip joint].