Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software

Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software - Study of PSG for THA, linked with 3D surgical support software (Study of PSG for THA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025768

Enrollment

Registered

2017-01-24

Start date

2017-01-24

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

Hip joint disease scheduled for total hip arthroplasty (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)

Interventions

Using patient specific guide linked with 3D surgical support software for total hip arthroplasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age more than 20 years, at the time of acquiring consent (2) Document consent canbe obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding

Exclusion criteria

Exclusion criteria: (1) Patients judged by the principal investigator to be inappropriate as subjects (2) Patients who have been registered in the past in this study (3) Patients with posterior pelvic inclination more than 20 degrees (4) Patients with or suspected to have Creutzfeldt-Jakob disease

Design outcomes

Primary

Measure	Time frame
Defference of stem antetorsion (by neck axis)between 3D pre-operative planning and post-operative implantation.	—

Secondary

Measure	Time frame
Differences between 3D pre-operative planning and post-operative implantation in the following items. -Stem angle differences in antetorsion (by stem axis), varus / valgus, and flextion / extension. -Depth from center of stem. -Stem spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z ( axial)-axis. -Cup angle differences in radiographic inclination (RI) and radiographic anteversion (RA). -Cup spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z(axial)-axis. Leg length discrepancy. Adverse event.	—

Measure

Time frame

Differences between 3D pre-operative planning and post-operative implantation in the following items. -Stem angle differences in antetorsion (by stem axis), varus / valgus, and flextion / extension. -Depth from center of stem. -Stem spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z ( axial)-axis. -Cup angle differences in radiographic inclination (RI) and radiographic anteversion (RA). -Cup spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z(axial)-axis. Leg length discrepancy. Adverse event.

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Countries

Japan

Contacts

Public ContactDaihei Kida

National Hospital Organization Nagoya Medical Center Orthopedic Surgery and Rheumatology

kidad@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

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