Evaluation of bone remodeling after total hip arthroplasty using Initia Stem

Not Applicable

• Conditions: Secondary osteoarthritis caused by hip dysplasia or osteonecrosis of the femoral head

• Registration Number: JPRN-UMIN000028512
• Lead Sponsor: Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-03
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with immature bone structure 2) Patients with the loss of abduction muscle in affected leg 3) Patients with insufficient bone mineral density (e.g. Corticosteroid-induced metabolic bone disease) 4) Patients with insufficient skin covering around the hip joint 5) Patients with neuromuscular disease (e.g. Charcot disease) in affected leg 6) Patients with the infection (e.g. osteomyelitis in proximal femur or purulent infection in the hip joint) 7) Patients with stovepipe-like femur 8) Patients with radiation osteonecrosis of acetabulum 9) Patients with systemic or local infection 10) Patients with vascular interruption in affected leg 11) Patients without the ability of walking at the postoperative time 12) Suspicious patients with metal allergy 13) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy 14) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder 15) Patients who need to undergo the lower extremity surgery within six months after participating in the study, including total hip arthroplasty and total knee arthroplasty 16) Patients who underwent the lower extremity surgery within six months before participating in the study, including total hip arthroplasty, total knee arthroplasty, or osteotomy 17) Patients who doctors judged unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the change of bone mineral density around the stem between Initia stem and Perfix HA 910 stem based on previous report describing the change of bone mineral density around cement-less stem.

Secondary Outcome Measures

Name	Time	Method
To examine the relationship of the change of bone mineral density around the cement-less stem with investigation items, including background, clinical assessment, radiograph, and patient-reported outcome.