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

NCT06942247 | Suspended

• 1 other identifier: QX20221007-X-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Silk fibroin bone screws; Fracture fixation; Knee and ankle joints; Safety and efficacy evaluation; Prognosis

Outcome Measures

Primary Outcomes (1)

• Cinical Fracture Healing Rate

  1. No local tenderness or longitudinal percussion pain, no local abnormal activity; 2. X-rays show a continuous bone scab or trabeculae crossing the fracture line at the fracture site and the fracture line has been blurred. If both of these are met, the fracture is considered healed, and vice versa. 3. Healing rate = (Healing cases / Total cases) ×100%

  24 weeks after surgery+4 weeks

Secondary Outcomes (20)

• Cinical Fracture Healing Rate

  12 weeks after surgery±1 week

• Cinical Fracture Healing Rate

  48 weeks after surgery± 4 weeks

• Cinical Fracture Healing Rate

  72 weeks after surgery± 4 weeks

• Visual Analogue Scale (VAS)

  During the screening period

• Visual Analogue Scale (VAS)

  Within 1 week after surgery (≤7 days)

Other Outcomes (158)

• Demographic Data

  Before surgery

• History of Disease and Treatment

  Before surgery

• Bone Mineral Density (BMD) Examination

  Before surgery

Study Arms (2)

Inion Freedom Screws

ACTIVE COMPARATOR

Patients were treated with screws developed by Inion Oy, Finland for the fixation of fractures in the knee and ankle joints.

Device: Active Comparator: Fracture Fixation (Inion Freedom Screws)

Biologic Hollow Bone Screws

EXPERIMENTAL

Patients were treated with screws developed by Jiangxi Sike Biotechnology, China for the fixation of fractures in the knee and ankle joints.

Device: Experimental: Fracture Fixation (Biological Hollow Bone Screws)

Interventions

Active Comparator: Fracture Fixation (Inion Freedom Screws) DEVICE

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.

Inion Freedom Screws

Experimental: Fracture Fixation (Biological Hollow Bone Screws) DEVICE

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.

Biologic Hollow Bone Screws

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old (inclusive), both sexes;
• Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination;
• Voluntary participation in the clinical trial and signing of the informed consent.

You may not qualify if:

• The following conditions exist at the fracture site: infection, osteofascial compartment syndrome, osteitis, pathological fracture, open fracture, severe tissue or vascular and nerve injury, or insufficient bone mass of the affected limb affecting screw implantation, etc.
• Abnormal liver and kidney function with clinical significance (ALT, AST 2 times the upper limit of normal value and Cr 2 times the upper limit of normal value);
• Abnormal coagulation function with clinical significance (APTT \> 2 times the upper limit of normal value);
• Patients with difficult-to-control diabetes (any blood glucose \> 11.1mmol/L or glycosylated hemoglobin \> 9%);
• Past allergies to silk protein materials;
• Mental illness;
• Patients who cannot guarantee to quit smoking during the fracture healing period;
• Pregnant or lactating women or women of childbearing age who plan to get pregnant within 6 months;
• Those who have participated in other pre-clinical trials within 1 month before the trial;
• Those who are considered inappropriate to participate in the clinical trial.

Sponsors & Collaborators

• FengYafei: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Xi'an, Shaanxi, 710032, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researchers can visually distinguish the experiment products and the control products, so the researchers cannot be blinded and the participants were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: The experimental group was treated with biologic hollow bone screws (Jiangxi Sike Biotechnology, China); the control group was treated with Freedom Screws (Inion Oy, Finland).

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: April 24, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)