Hip joint disease that improves the hip joint function and patients
Conditions
Interventions
None listed
Sponsors
Jilei University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Has provided written informed consent for study participation 2 Patients of Japanese descent, of either gender, 20 years of age or older 3 A candidate for total hip arthroplasty (THA) due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant 4 Willing and able to comply with study visit schedule including all follow-up visits 5 Has no disease or conditions that in the opinion of the Investigator would compromise the study or would pose a risk due to study participation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate bone mineral density in Gruen zone 7 of the HA coated POLARSTEM two years post-operatively using the POLAR3 Hip System | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess perioperative clinical and safety outcomes after Total Hip Arthroplasty (THA) with POLAR3 Hip system: 1 X-ray evaluation (alignment, bone reaction) 2 Tomosynthesis evaluation (bone reaction) 3 Bone mineral density evaluation using Dual-energy X-ray absorptiometry (DEXA) 4 Harris Hip Score (HHS) 5 Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) 6 Adverse event (AE) 7 Device Deficiency (DD) | — |
Countries
Japan
Contacts
Public ContactWataru Taguchi
Smith & Nephew KK Clinical Affairs
Outcome results
None listed