Phase
Condition
Arthritis And Arthritic Pain
Arthritis And Arthritic Pain (Pediatric)
Osteoarthritis
Treatment
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
Clinical Study ID
Ages 50-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient requires primary THA due to NIDJD or any of its composite diagnoses such asosteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capitalepiphysis, fracture of the pelvis, and diastrophic variant requiring unilateralprimary THA.
Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time ofenrollment.
Patient has preoperative medical clearance and is free from or treated for medicalconditions 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 theinvestigational site and to complete study procedures and questionnaires.
Exclusion
Exclusion Criteria:
Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateralhip in the last 24 months.
Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateralhip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2on a Numeric Rating Scale 0-10.
Patient needs bilateral hip replacement or has a planned THA on the contralateralhip 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 ofthe 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 ineither leg (based on the Investigator's judgment).
Patient has a deformity of the affected limb or significant anatomic variance of theaffected hip.
Patient has an active malignancy or history of invasive malignancy within the last 5years, except for superficial basal cell carcinoma or squamous cell carcinoma of theskin that has been definitively treated. Patients with carcinoma in situ of theuterine cervix definitively treated more than 1 year prior to enrollment may enterthe study.
Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoidarthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenilerheumatoid arthritis, and other arthritic processes of inflammatory or autoimmuneetiology.
Patient has any condition that would interfere with self-assessment of pain,function, or quality of life (QoL) required for patient-reported outcomes during thestudy (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 DeficiencySyndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of theintended surgery.
Patient is currently participating in any investigational study not related to thisstudy'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.
Study Design
Study Description
Connect with a study center
Miami Institute for Joint Reconstruction
Miami, Florida 33186
United StatesActive - Recruiting
Advent Health Hospital, Carrollwood
Tampa, Florida 33614
United StatesActive - Recruiting
Tampa General Health / Florida Orthopedic Institute
Tampa, Florida 33615
United StatesSite Not Available
LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland 21215
United StatesActive - Recruiting
Division of Orthopaedic Surgery
Somers Point, New Jersey 08244
United StatesActive - Recruiting
JIS Orthopedics
New Albany, Ohio 43054
United StatesActive - Recruiting
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