The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface
Phase 1
- Conditions
- Disease around the wrist
- Registration Number
- JPRN-UMIN000006112
- Lead Sponsor
- Orthopaedic Surgery, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of the coating screws: evaluation of the incidence of adverse events including secondary fracture, severe pin-tract infection
- Secondary Outcome Measures
Name Time Method 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)