A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)

Not Applicable

• Conditions: Hip joint disease that improves the hip joint function and patients

• Registration Number: JPRN-UMIN000043074
• Lead Sponsor: Jilei University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 20 November 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

1Acute or chronic infection, local or systemic 2Severe muscle, nerve, or vascular diseases that endanger the extremity 3Has previously received THA in the index joint 4Any of the following conditions in the contralateral joint: Has received THA as a revision for a failed procedure Has received THA that is not fully healed and well-functioning in the opinion of the Investigators 5Current diagnosis of immunosuppressive disorder 6History of cancer within 5 years of screening 7Known allergy to any component of the study device 8Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease 9Current diagnosis of fibromyalgia 10 Mass Index (BMI) over 40 11 Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening 12Has previously history of femur neck fracture 13Acetabular osteotomy in the index joint

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate bone mineral density in Gruen zone 7 of the HA coated POLARSTEM two years post-operatively using the POLAR3 Hip System

Secondary Outcome Measures

Name	Time	Method
To assess perioperative clinical and safety outcomes after Total Hip Arthroplasty (THA) with POLAR3 Hip system: 1X-ray evaluation (alignment, bone reaction) 2Tomosynthesis evaluation (bone reaction) 3Bone mineral density evaluation using Dual-energy X-ray absorptiometry (DEXA) 4Harris Hip Score (HHS) 5Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) 6Adverse event (AE) 7Device Deficiency (DD)