Clinical trial on the safety and effectiveness of biodegradable magnesium alloy bone screws for internal fracture fixation, osteotomy and arthrodesis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063592

Enrollment

Unknown

Registered

2022-09-13

Start date

2022-09-12

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

Internal fixation of fracture, osteotomy and arthrodesis

Interventions

Trial Group:Fix the fracture with magnesium alloy bone screws

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The subjects or guardians are willing and able to sign an informed consent form; (2) The age is 18~65 years old (including), gender is not limited; (3) Freshly fractured patients; (4) Patients requiring internal fixation, osteotomy and arthrodesis in non-weight bearing areas; (5) Good compliance, willing and able to follow up for observation as required.

Exclusion criteria

Exclusion criteria: (1) Infection of the whole body or at the surgical site; (2) Insufficient bone mass at the implant site to hold the implant in place ; (3) Patients with osteomyelitis; (4) Pathological fractures at the surgical site; (5) Fracture combined with osteo-fascial compartment syndrome; (6) Metabolic bone disease (except senile osteoporosis); (7) Patients with malignant tumors; (8) Severe multiple injuries (accompanied by severe brain injury or multiple organ injury, etc.); (9) Patients on systemic corticosteroid use; (10) Patients who are using growth factors; (11) Long term use of sedative-hypnotics (more than 3 months of continuous use); (12) Long term use of non-steroidal anti-inflammatory drugs (more than 3 months of continuous use); (13) People who are allergic to the materials used in the product; (14) Lactating or pregnant women; (15) Mental illness, drug abuse, alcoholics; (16) Severe heart, liver, kidney, lung, blood system and other diseases that cannot tolerate surgery; (17) Subjects participated in other clinical studies 3 months before enrollment.

Design outcomes

Primary

Measure	Time frame
Fracture healing rate at 3 months after operation;Fracture healing rate at 6 months after operation;Comprehensive evaluation of efficiency;Product performance evaluation;AE/SAE;Local adverse reactions;Postoperative fracture redisplacement, bone non-union, delayed bone healing;Laboratory examination;Vital signs;	—

Countries

China

Contacts

Public ContactTian Wen, Yang Yong

wentiansyz@hotmail.com010-58516688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026