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Evaluation of bone remodeling after total hip arthroplasty using Initia Stem

Evaluation of bone remodeling after total hip arthroplasty using Initia Stem - Bone remodeling after THA using Initia Stem

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028512
Enrollment
200
Registered
2017-08-03
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Total hip arthroplasty using Initia Stem Total hip arthroplasty using Perfix HA 910 stem

Sponsors

Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Primary total hip arthroplasty 2) Age: 20-75 years old 3) Male and Female 4) Patients with the ability of consent and writing 5) Patients who can visit hospital as scheduled during the research period

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactGoro Motomura

Graduate School of Medical Sciences, Kyushu University Department of Orthopaedic Surgery

goromoto@ortho.med.kyushu-u.ac.jp092-642-5488

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026