Accelerometer-Based Navigation Versus Conventional Alignment Guide for Acetabular Component Placement in Total Hip Arthroplasty: A Randomized, Controlled Trial: Comparisons of computed tomographic outcomes and liner-to-neck clearances during weight-bearing activities

Not Applicable

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

• Registration Number: JPRN-UMIN000031726
• 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: 2018-03-14
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

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
To evaluate with the validated image matching technique whether the accelerometer-based navigation device (HipAlign system, Zimmer Biomet, Warsaw, IN, USA) provides significantly larger distances between the acetabular liner and the stem neck (liner-to-neck clearance) during daily activities compared to conventional alignment guide.

Secondary Outcome Measures

Name	Time	Method
To evaluate with CT images whether the accelerometer-based navigation device (HipAlign system, Zimmer Biomet, Warsaw, IN, USA) provides significantly higher precisions in the acetabular cup alignment compared to conventional alignment guide.