Non-inflammatory degenerative hip joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, and diastrophic variant
Conditions
Interventions
None listed
Sponsors
Kansai Rousai 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: 1)Acute or chronic infection, local or systemic. 2)Severe muscle, nerve, or vascular diseases that endanger the extremity. 3)Has previously received THA in the index joint. 4)Any 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 Investigator. 5)Current diagnosis of immunosuppressive disorder. 6)History of cancer within 5 years of screening. 7)Known allergy to any component of the study device. 8)Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease. 9)Current diagnosis of fibromyalgia. 10)Body Mass Index (BMI) > 40. 11)Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) Total Score between baseline and 730 days post-operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Cumulative revision rate for each femoral stem at each follow-up visit. 2)Change in Harris Hip Score (HHS) between baseline and each follow-up visit. 3)Change in the 3 dimensions of the JHEQ between baseline and each follow-up visit. 4)Change in pain as measured by the Visual Analogue Scale (VAS) between baseline and each follow-up visit. 5)Changes in EQ-5D-5L and in EQ-5D-5L-derived Quality Adjusted Life Years (QALY) between baseline and each follow-up visit. 6)Radiographic outcomes. 7)Comparison of revision rate, HHS, 3 dimensions and total score of JHEQ, pain, and EQ-5D-5L including QALY between subjects with and without a diagnosis of osteoporosis at each of the follow-up visits. | — |
Countries
Japan
Contacts
Public ContactRyo Hasegawa
Smith & nephew KK North Asia Clinical Strategy and Operation
Outcome results
None listed