MonoPlus® in Orthopedic Surgery (UNITE)

Aesculap

Status

Completed

Conditions

Orthopedic Surgery

Soft Tissue Approximation

Treatments

Device: MonoPlus®

Study type

Observational

Funder types

Industry

Identifiers

NCT05257278

AAG-O-H-2027

Details and patient eligibility

About

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

Full 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.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.