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Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation on THA in Lateral Decubitus position

Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation - AR Hip RCT on THA in lateral decubitus position

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047608
Enrollment
100
Registered
2022-05-01
Start date
2022-06-10
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 Arthroplasty

Interventions

G7 acetabular system THA with AR Hip System as the Control group G7 acetabular system THA without AR Hip System as the Control group

Sponsors

Hokusuikai Kinen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 20 to 80 years of age, inclusive - Skeletally mature - Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques - Type 1 or Type2 of Crowe classification - Willing and able to complete scheduled follow-up evaluations as described in the study protocol - Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion criteria

Exclusion criteria: - Has an anteversion of 20 degrees or more at the target placement angle - Has an excessive flexion contracture - Has an asymmetric pelvis - Has a history of hip surgery on the affected side - Judged as inappropriate subject by surgeons performing regenerative medicine

Design outcomes

Primary

MeasureTime frame
The difference between the target placement angle and the postoperative placement angle between the AR Hip group and the conventional group.

Secondary

MeasureTime frame
The influence of surgery time / Incidence of adverse event after THA / Harris Hip Score and JHEQ degree of improvement / Acetabular Cup alignment accuracy

Countries

Japan

Contacts

Public ContactYukako Shiraishi

Zimmer Biomet G.K. Clinical Affairs

yukako.shiraishi@zimmerbiomet.com03-6402-6600

Outcome results

None listed

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