MonoPlus® in Orthopedic Surgery

NCT05257278 | Completed

• 1 other identifier: AAG-O-H-2027
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthopedic Surgery; Soft Tissue Approximation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in functional performance for Patients undergoing Knee surgery

  preoperatively, 6 weeks and 3 months post-surgery

• Changes in functional performance for Patients undergoing Hip surgery

  preoperatively, 6 weeks and 3 months post-surgery

• Changes in functional performance for Patients undergoing upper extremity surgery

  preoperatively, 6 weeks and 3 months post-surgery

• Changes in strength

  at baseline, 6 weeks and 3 months post-surgery.

• Incidence of reoperations

  Up to last follow up 12 months post operatively

Study Arms (1)

MonoPlus®

Patients undergoing orthopedic surgery with soft tissue approximation

Device: MonoPlus®

Interventions

MonoPlus® DEVICE

MonoPlus® is indicated for use in general soft tissue approximation, specially in cases where extended wound support of more than 4 weeks is desirable

MonoPlus®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Study Officials

• Pablo Sanz Ruiz

  Gregorio Marañón Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 25, 2022
• Study Start: January 18, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)