NCT05431790

Absorbable Interface Screw Clinical Trial

Absorbable Interface Screw Clinical Trial - PUTH & NANTON

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Validation of the safety and efficacy of absorbable interface screws for clinical use

Detailed description

Interface screws are divided into metal screws and absorbable screws. Since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. At present, the materials of absorbable screws are mainly polylactic acid and polyglycolide. The test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.Estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	Absorbable interface screws manufactured by Natong Biotechnology	Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
DEVICE	Absorbable interface screws manufactured by INION.	Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland

Timeline

• Start date: 2022-07-30
• Primary completion: 2023-05-30
• Completion: 2023-06-30
• First posted: 2022-06-24
• Last updated: 2022-06-24