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The Alternative Technique to Reduce Radiation Exposure during Locked Plate Fixation of Distal Radius Fracture; the Plummet as a Targeting Device

A Randomized Controlled Trial Evaluating a Mechanical Plummet Aiming Device to Reduce Fluoroscopic Radiation Exposure During Volar Locking Plate Fixation of Unstable Distal Radius Fractures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251229001
Enrollment
38
Registered
2025-12-29
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Unstable distal radius fractures requiring surgical fixation with volar locking plate Radiation exposure Intraoperative fluoroscopy Distal radius fracture Aiming devices

Interventions

Plummet-assisted volar locking plate fixation Patients underwent standard volar locking plate fixation using intraoperative fluoroscopic imaging with a plummet weighed 100 grams, was made of polished
s judgment without any aiming device. (Conventional fluoroscopy)
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Plummet group,Control group

Sponsors

Nitiwut Saenmanot
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient aged 18 years or older. 2. Patients diagnosed with unstable distal end radius fractures. 3. Patients scheduled for open reduction and internal fixation with volar locking plate fixation in Kumpawapi Hospital between June and September 2025. 4. Patients who provided written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Age under 18 years 2. Refusal to participate 3. Unfit for surgery or anesthesia

Design outcomes

Primary

MeasureTime frame
Total number of fluoroscopic images Intraoperative Count recorded automatically from C-arm,Radiation exposure dose (uSv) Intraoperative Dose output automatically from C-arm,Total radiation time (minutes) Intraoperative Recorded automatically from C-arm

Secondary

MeasureTime frame
Operative time (minutes) Intraoperative Stopwatch measurement,Fluoroscopic accuracy (%) Intraoperative Ratio of accurate views to total images,Postoperative wound infection Post operation at 2, 4, 6 weeks Clinical evaluation

Countries

Thailand

Contacts

Public ContactNitiwut Saenmanot

Orthopaedic department, Kumpawapi Hospital, Udon Thani, Thailand

nitiwut.ortho@gmail.com042334400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026