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A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws

NCT06942247 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-11

No results posted yet for this study

Summary

Traditional fracture fixation devices can cause corrosion, allergies, and stress shielding effects. They often require removal after healing, risking secondary damage. Recently, biodegradable materials have gained attention for their effective clinical use in fracture fixation. Absorbable bone nails, for example, eliminate the need for a second surgery, reducing pain and costs while avoiding infection and tissue re-injury. They do not corrode and are invisible on X-rays, allowing for thorough patient examination and better fracture healing assessment.

Conditions

  • Fracture Fixation, Internal

Interventions

DEVICE

Active Comparator: Fracture Fixation (Inion Freedom Screws)

Device: Absorbable screw for internal fixation of fracture. Patients were divided into the Inion Freedom Screws group and the Biological Hollow Bone Screws group according to the type of the screws they used.

DEVICE

Experimental: Fracture Fixation (Biological Hollow Bone Screws)

Device: Absorbable screw for internal fixation of fracture. Patients were divided into the Inion Freedom Screws group and the Biological Hollow Bone Screws group according to the type of the screws they used.

Sponsors & Collaborators

  • FengYafei

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942247 on ClinicalTrials.gov