MonoPlus® in Orthopedic Surgery (UNITE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Orthopedic Surgery; Soft Tissue Approximation
• Intervention / Treatment: Device: MonoPlus®

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MonoPlus®; Patients undergoing orthopedic surgery with soft tissue approximation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of maintained soft tissue approximation	For the assessment of MonoPlus® effectiveness the percentage of patients that maintain soft tissue approximation integrity examined by ultrasound is evaluated	3 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional performance for Patients undergoing Knee surgery	Mean changes in functional performance from baseline to week 6 and month 3 after surgery according to the Oxford Knee Score (OKS). OKS is a short 12-item patient-reported outcome(PRO) specifically designed and developed to assess function and pain with patients undergoing knee replacement surgery. When the OKS was originally developed, it was designed to be as simple as possible for ease of use. The scoring system is a 0-5 where one represented the best outcome. Item scores are summed to give a total score. The lower the score, the better the outcome.	preoperatively, 6 weeks and 3 months post-surgery
Changes in functional performance for Patients undergoing Hip surgery	Mean changes in functional performance from baseline to week 6 and month 3 after surgery according to the Oxford Hip Score (OHS). The Oxford Hip Score (OHS) is a short 12-item patient-reported patient-reported outcome (PRO) specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. Each item has five possible responses from 0 to 5. Item scores are summed to give a total score. The lower the score, the better the outcome.	preoperatively, 6 weeks and 3 months post-surgery
Changes in functional performance for Patients undergoing upper extremity surgery	Mean changes in functional performance from baseline to week 6 and month 3 after surgery according to the Quick Disability of Arm, Shoulder and Hand score (QuickDASH). The QuickDASH,is a subset of 11 items from the 30-item Disability of Arm, Shoulder and Hand score and is a self-reported questionnaire. The response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.	preoperatively, 6 weeks and 3 months post-surgery
Changes in strength	Mean changes in strength measured by a dynamometer from baseline to week 6 and month 3 after surgery.	at baseline, 6 weeks and 3 months post-surgery.
Incidence of reoperations	Frequency of reoperation within the 12 months after surgery.	Up to last follow up 12 months post operatively
The length of hospital stay after the orthopedic surgery.	Mean duration of hospital stay in patients undergoing orthopedic surgery.	up to hospital discharge (approximately 10 days postoperatively)
The incidence of post-surgery complicated wound healing.	Frequency of patients with complicated wound healing within the first 6 weeks post-surgery. A complicated wound healing will be recorded if the incision does not close completely, necrosis of the wound edge or primary or secondary dehiscence occur, or in cases of formation of a seroma, fistula, or bleeding.	12-month study follow-up.
The incidence of wound infections during the study follow-up.	Frequency of wound infections within the 12-month post-surgery follow-up. Wound infection is defined as redness, wound dehiscence with secretion (putrid or caliginous fluid), and / or microbiological evidence of bacterial contamination.	12-month study follow-up.
Development of Pain measured with Visual Analogue Scale (VAS)	Mean pain VAS scores at rest and with activity at five different points of time (baseline, hospital discharge, 6 weeks, 3 months and 12 months after surgery. Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).	Preoperatively, hospital discharge (approximately 10 days postoperatively), 6 weeks, 3 months and 12 months after surgery
Rate of Adverse Device Effects	Frequencies of patients with Adverse Device Effects (ADE) reported until month 12 after surgery.	up to last follow-up at 12 months postoperatively
Assessment of intraoperative handling of suture material	Assessment of intraoperative handling of suture material using a questionnaire (Likert Scale) including various dimensions (knot security, tensile strength, knot run down, tissue drag and pliability) with 5 evaluation levels ('excellent' (5), 'very good' (4), 'good' (3), 'satisfied' (2) and 'poor' (1)).	intraoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Pablo Sanz Ruiz, Gregorio Maranon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): July 7, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AAG-O-H-2027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No