Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery
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
140
MonoPlus® is indicated for use in general soft tissue approximation, specially in cases where extended wound support of more than 4 weeks is desirable
Hospital Gregorio Marañón
Madrid, Spain
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
Time frame: 3 months post-surgery
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: at baseline, 6 weeks and 3 months post-surgery.
Incidence of reoperations
Frequency of reoperation within the 12 months after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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)).
Time frame: intraoperatively