The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface

The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface - The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006112

Enrollment

Registered

2011-10-01

Start date

2011-10-01

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

Disease around the wrist

Interventions

Coating screws prepared only using clinically approved materials are percutaneously implanted in patients to whom external fixator should be applied for disease around the wrist

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with disease around the wrist to whom monolateral external fixator should be applied. 2)Between 20 to 75 years of age

Exclusion criteria

Exclusion criteria: 1)Dermatological disease 2)Severe complication (including cardiac, liver and renal diseases) 3)History of malignancy in the last 5 years from the consent date for this study, or suspicion of malignancy 4)Pregnant or possibly pregnant women 5)Incapableness of consent due to cognitive problem 6)Incapableness of consent in writing 7)Any other reasons when the doctor-in-charge considered to be unsuitable in this study

Design outcomes

Primary

Measure	Time frame
Safety assessment of the coating screws: evaluation of the incidence of adverse events including secondary fracture, severe pin-tract infection	—

Secondary

Measure	Time frame
Assessment either fixation strength of the coating screws or pin-tract infection. 1)Macroscopic findings of pin-tract infection (grading according to the Checketts & Otterburn classification) 2)Bacterial inspection surrounding the coating screws 3)Evaluation of bone surrounding the coating screws using X-ray and CT scanning 4)Inspection of surfaces of extracted coating screw using a microscope 5)Measurement of pain caused by extraction of the coating screws (according to the visual analog scale (VAS)) 6)Measurement of fixation strength in bone-screw interface (insertion and extraction torque)	—

Measure

Time frame

Assessment either fixation strength of the coating screws or pin-tract infection. 1)Macroscopic findings of pin-tract infection (grading according to the Checketts & Otterburn classification) 2)Bacterial inspection surrounding the coating screws 3)Evaluation of bone surrounding the coating screws using X-ray and CT scanning 4)Inspection of surfaces of extracted coating screw using a microscope 5)Measurement of pain caused by extraction of the coating screws (according to the visual analog scale (VAS)) 6)Measurement of fixation strength in bone-screw interface (insertion and extraction torque)

—

Countries

Japan

Contacts

Public ContactHirotaka Mutsuzaki

Ibaraki Prefectural University of Health Sciences Hospital Orthopaedic Surgery

mutsuzaki@ipu.ac.jp029-888-9200

Outcome results

None listed

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