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Randomized controlled trial of open osteosynthesis for unstable trochanteric fractures

Open label randomized parallel group comparison trial of short nail and middle nail with open osteosynthesis for unstable trochanteric fractures - ROUT Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047700
Enrollment
60
Registered
2022-05-10
Start date
2022-05-10
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

unstable trochanteric fractures

Interventions

Open osteosynthesis using short nails for unstable trochanteric fractures. Open osteosynthesis using middle nails for unstable trochanteric fractures.

Sponsors

Shuto General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient with a first time trochanteric fracture and classified as unstable on imaging evaluation. Patients who have been fully informed and have given written consent to participate in this study.

Exclusion criteria

Exclusion criteria: Patients for whom long nails, artificial head replacement, etc. are considered appropriate. Patients who have difficulty with postoperative imaging evaluation.

Design outcomes

Primary

MeasureTime frame
Maintenance rate of the reduction position at 3 months postoperatively.

Secondary

MeasureTime frame
Length of telescoping and status of bone fusion on x-ray at 3 weeks and 3 months postoperatively. NRS, BI, FIM, grip strength, and gait at 3 weeks and 3 months postoperatively.

Countries

Japan

Contacts

Public ContactShotaro Kawano

Shuto General Hospital Orthopedics

sk.ymbadc@gmail.com0820-22-3456

Outcome results

None listed

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