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A prospective, single-center, single-arm clinical study of the efficacy and safety of absorbable bone screws for bone fixation of the hand and foot in a Chinese population

A prospective, single-center, single-arm clinical study of the efficacy and safety of absorbable bone screws for bone fixation of the hand and foot in a Chinese population

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100535
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Patients with fractures or fusions of the hand or foot requiring surgery.

Interventions

Absorbable bone screw group:Bone fixation with absorbable bone screws

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~70 years old, both male and female; 2. Screw fixing is used for the first time; 3. Subjects with fractures or fusions of the hand or foot requiring surgery; 4. Voluntary participation and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. pathological fractures due to bone disease (benign or malignant tumors, tuberculosis, osteomyelitis, endocrine metabolic and other factors). 2. patients with anatomical anomalies and excessive bending of the diaphysis. 3. the implant is expected to be subjected to high mechanical loads. 4. severe comminuted fractures, osteoporosis that prevents effective fixation of the implant. 5. fractures with localized soft tissue damage and defects without adequate tissue coverage at the implant site. 6. at sites of bone marrow inflammation, septic infection, or other soft tissue infection. 7. patients with suspected or confirmed allergy to the implanted material. 8. Patients with contraindications to anesthesia and surgery; 9. Pregnant and breastfeeding women; 10. patients with co-morbid rheumatologic diseases that may affect the evaluation of the test results as assessed by the investigator; 11. the presence of sensory deficits which, as assessed by the investigator, affect the evaluation of the results of the test. 12. the presence of a psychiatric disorder that, in the opinion of the Investigator, affects the evaluation of the results of the trial. 13. any condition that, in the opinion of the Investigator, may increase the risk to the subject or interfere with the clinical trial.

Design outcomes

Primary

MeasureTime frame
Fracture healing rates in subjects with hand and foot fractures or fusions at 6 months after surgery.;

Countries

China

Contacts

Public ContactLiu Bin

The First Hospital of Jilin University

kjkliubin@126.com+86 431 88788009

Outcome results

None listed

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