Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2022-01-18
2024-07-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MonoPlus®
Patients undergoing orthopedic surgery with soft tissue approximation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Need for orthopedic surgery
* Use of MonoPlus® for the orthopedic surgery in the routine clinical practice
* Written informed consent form.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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B.Braun Surgical SA
INDUSTRY
Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Pablo Sanz Ruiz
Role: PRINCIPAL_INVESTIGATOR
Gregorio Marañón Hospital
Locations
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Hospital Gregorio Marañón
Madrid, , Spain
Countries
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Other Identifiers
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AAG-O-H-2027
Identifier Type: -
Identifier Source: org_study_id
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