MonoPlus® in Orthopedic Surgery

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

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

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.

Inclusion Criteria:

• Male or female patients
• Need for orthopedic surgery
• Use of MonoPlus® for the orthopedic surgery in the routine clinical practice
• Written informed consent form.

Exclusion Criteria:

• Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
• Prosthetic surgery secondary to infection
• Radiation to the surgical area
• Participation or planned participation in any clinical trial before study follow-up is completed
• Previous tendon/ligament repair intervention
• Pregnancy
• Patients with hypersensitivity or allergy to the suture material
• Patients taking medical consumption that might affect wound healing.