Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed

Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed - Multi-center randomized controlled blind study of LC-4308

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032281

Enrollment

Registered

2018-04-17

Start date

2017-12-08

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

Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed

Interventions

LC-4308 (Adhesion Barrier System) Standard of care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients provided written informed consent (2)Patients aged 20 years or older at the time of informed consent (3)Patients who are diagnosed A2, A3, C1 or C2 by AO classification (4)Patients who are able to keep splint for 1 week (5)Patients who are scheduled to be removed locking plate (6)Patients who are able to be tested according to the plan (7)Patients who have surgery within 2 weeks after injury

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Adhesion at locking plate removal	—

Countries

Japan

Contacts

Public ContactShinji Namoto

JMS CO.,LTD. Clinical Research Section Regulatory Affairs and Quality Assurance Division

s-namoto@jms.cc082-243-6033

Outcome results

None listed

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