Clinical trial NCT05257278: MonoPlus® in Orthopedic Surgery
Official title: Single-center PMCF - Study on the Performance and Safety of MonoPlus® in Patients Undergoing Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Surgery
Soft Tissue Approximation
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-02-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male of femal patients are eligible for inclusion in this study when they are in need of orthopedic surgery and MonoPlus® is used for soft tissue approximation for this orthopedic surgery in the routine clinical practice

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® 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of maintained soft tissue approximation
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Changes in functional performance for Patients undergoing Knee surgery
timeFrame: preoperatively, 6 weeks and 3 months post-surgery
measure: Changes in functional performance for Patients undergoing Hip surgery
timeFrame: preoperatively, 6 weeks and 3 months post-surgery
measure: Changes in functional performance for Patients undergoing upper extremity surgery
timeFrame: preoperatively, 6 weeks and 3 months post-surgery
measure: Changes in strength
timeFrame: at baseline, 6 weeks and 3 months post-surgery.
measure: Incidence of reoperations
timeFrame: Up to last follow up 12 months post operatively
measure: The length of hospital stay after the orthopedic surgery.
timeFrame: up to hospital discharge (approximately 10 days postoperatively)
measure: The incidence of post-surgery complicated wound healing.
timeFrame: 12-month study follow-up.
measure: The incidence of wound infections during the study follow-up.
timeFrame: 12-month study follow-up.
measure: Development of Pain measured with Visual Analogue Scale (VAS)
timeFrame: Preoperatively, hospital discharge (approximately 10 days postoperatively), 6 weeks, 3 months and 12 months after surgery
measure: Rate of Adverse Device Effects
timeFrame: up to last follow-up at 12 months postoperatively
measure: Assessment of intraoperative handling of suture material
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
Study officials:
affiliation: Gregorio Marañón Hospital
name: Pablo Sanz Ruiz
role: PRINCIPAL_INVESTIGATOR
References: