NCT05257278

MonoPlus® in Orthopedic Surgery

Single-center PMCF - Study on the Performance and Safety of MonoPlus® in Patients Undergoing Orthopedic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery

Detailed description

This post-market clinical follow-up (PMCF) study on the use of MonoPlus®, a polydioxanone absorbable suture material, will expand the information available on the performance and safety of MonoPlus® used for orthopedic surgeries conducted in daily practice conditions. The study is designed as a prospective, non-interventional, single-center, PMCF cohort study. The product under investigation will be used in routine clinical practice and according to the Instructions for Use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.

Conditions

• Orthopedic Surgery
• Soft Tissue Approximation

Interventions

Type	Name	Description
DEVICE	MonoPlus®	MonoPlus® is indicated for use in general soft tissue approximation, specially in cases where extended wound support of more than 4 weeks is desirable

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-07-07
• Completion: 2024-07-07
• First posted: 2022-02-25
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain