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) - 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)

Jilei University Hospital0 sites152 target enrollmentJanuary 21, 2021

Overview

Phase: 未知
Intervention: Not specified
Conditions: Hip joint disease that improves the hip joint function and patients
Sponsor: Jilei University Hospital
Enrollment: 152
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

January 21, 2021

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Jilei University Hospital

•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