Status:
COMPLETED
MonoPlus® in Orthopedic Surgery
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Orthopedic Surgery
Soft Tissue Approximation
Eligibility:
All Genders
18+ years
Brief 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® u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 7 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05257278
Start Date
January 18 2022
End Date
July 7 2024
Last Update
September 19 2024
Active Locations (1)
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1
Hospital Gregorio Marañón
Madrid, Spain, 28007