A single-center, open-label, exploratory clinical trial to evaluate the efficacy and safety of the Clavicle Hook Plate product during surgery in patients with shoulder dislocation or clavicle tip fractures

A Single-Center, Open-Label, Exploratory Clinical Trial to Evaluate the Efficacy and Safety of the Clavicle Hook Plate in Patients with Acromioclavicular Joint dislocation or distal clavicle fracture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010449

Enrollment

Registered

2025-04-29

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-05-07

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

Conditions

None listed

Interventions

Medical Device : Pre-Operation: Baseline examination after admission Operation: Surgery 1) Under general anesthesia, skin preparation and draping are performed with the patient in the supine position.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 80 years old 2) Those requiring surgery due to acromioclavicular joint dislocation or distal clavicle fracture 3) Those aged 70 years or older with a K-MMSE score of 24 or higher 4) Those who fully understand the purpose and procedure of the trial and wish to participate in the clinical trial through voluntary consent

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women, or women of childbearing age who have not agreed to maintain contraception during the clinical period 2) Patients who have undergone internal fixation using metal nails 3) Patients with other fractures in the ipsilateral upper limb 4) Patients with pathological fractures 5) Patients with active infection or spondylitis 6) Patients with spinal disorders due to severe musculoskeletal, neurological, or vascular diseases 7) Those who cannot follow postoperative instructions during the postoperative recovery process 8) Those who the investigator determines are unsuitable for clinical study participation for other reasons 9) Those who are currently participating in another clinical trial or have participated in another clinical trial within 1 month prior to registration in this clinical trial

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale	—

Secondary

Measure	Time frame
Korean Shoulder scoring system;American Shoulder and Elbow Surgeons shoulder score;Radiological examination (X-ray);Radiological examination (CT);Radiological examination (MRI);Range of Motion;Safety assessment (adverse reaction test)	—

Countries

Korea, Republic of

Contacts

Public ContactSEUNG-ROK KANG

Jeonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results