Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
- Conditions
- Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
- Registration Number
- JPRN-UMIN000032281
- Lead Sponsor
- JMS CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(1)Patients with an open fracture in the target site (2)Patients complicated by other site fractures which may influence the evaluation of end points (3)Patients with the possibility of the rupture of tendon, main nerve, or blood vessels in the target site (4)Patients with the possibility of the combination of Artificial bones (5)Patients with the possibility of the placement of the locking plate beyond the watershed line (6)Patients unable to follow the instruction of rehabilitation (7)Patients who have limited range of motion of either one or both thumbs (8)Patients with high risk of fracture from the continuous treatment of oral steroids (9)Patients with serious Cardiovascular diseases, Liver diseases, Respiratory diseases, Malignancy or Immunodeficiency at registration (10)Patients with a history of severe drug allergies (11)Patients with a history of Biodegradable plastic allergies (12)Uncontrollable Diabetes mellitus (13)Patients with pregnancy or possible pregnancy, patients who are breast-feeding, and patients who cannot prevent pregnancy properly until locking plate removal after informed consent (14)Patients with Rheumatoid arthritis (15)Patients who are continuing to undergo or have not yet finished their tests or other clinical studies under informed consent (16)Others, patients who are judged as inadequately by principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method