RECRUITING

Safety and Effectiveness of the HIT Reverse HRS

Conditions

Degenerative Joint Disease Osteoarthritis, Hip Avascular Necrosis of Hip Traumatic Arthropathy-Hip total hip arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.

Official Title

Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study

Quick Facts

Study Start:2022-07-15

Study Completion:2035-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05357378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment. * Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk. * Patient has a signed and dated Informed Consent Form (ICF). * 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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months. * Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10. * Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months. * Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months. * Patient has a known allergy to titanium and/or XLPE. * Patient has known metal sensitivities to cobalt chromium (CoCr). * Patient has a history of septic arthritis in the index joint. * Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is 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 judgment). * 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 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study. * Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia. * Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology. * Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment). * Patient has a Body Mass Index (BMI) of 40 or higher. * 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 is currently participating in any investigational study not related to this study's preoperative or postoperative care. * Patient is currently pregnant or is planning to become pregnant during the study. * Patient is a competitive or professional athlete.

Inclusion Criteria

Exclusion Criteria

* 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.
* Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
* Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
* Patient has a signed and dated Informed Consent Form (ICF).
* 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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
* Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
* Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
* Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
* Patient has a known allergy to titanium and/or XLPE.
* Patient has known metal sensitivities to cobalt chromium (CoCr).
* Patient has a history of septic arthritis in the index joint.
* Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is 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 judgment).
* 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 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study.
* Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
* Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.
* Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).
* Patient has a Body Mass Index (BMI) of 40 or higher.
* 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 is currently participating in any investigational study not related to this study's preoperative or postoperative care.
* Patient is currently pregnant or is planning to become pregnant during the study.
* Patient is a competitive or professional athlete.

Contacts and Locations

Study Contact

George Diamantoni

CONTACT

1-866-832-4471

g.diamantoni@hit-irh.com

Study Locations (Sites)

Division of Orthopaedic Surgery

Somers Point, New Jersey, 08244

United States

JIS Orthopedics

New Albany, Ohio, 43054

United States

Collaborators and Investigators

Sponsor: Hip Innovation Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-15

Study Completion Date2035-07-15

Study Record Updates

Study Start Date2022-07-15

Study Completion Date2035-07-15

Terms related to this study

Keywords Provided by Researchers

total hip arthroplasty

Additional Relevant MeSH Terms

Degenerative Joint Disease
Osteoarthritis, Hip
Avascular Necrosis of Hip
Traumatic Arthropathy-Hip