Meniscal rupture Meniscal tear
Conditions
Interventions
Routine meniscectomy procedure with the steerable punch instead of ordinary
punches.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 16 years or older; - diagnosed with a traumatic meniscal tear; - scheduled for an operation to cut the traumatic meniscal tear.
Exclusion criteria
Exclusion criteria: - Systemic disease; - Previous meniscal/knee operations; - Degenerative meniscal tear or osteochondritis dissecans - No laxity of the knee (anterior/posterior drawer test of no more than 6 mm and negative Lachman test) - Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is safety, expressed by the instrument intactness during ten cycles of cleaning, sterilisation and use during a meniscectomy procedure. That is no failure will occur in terms of breakage or bending of parts or rejection in the cleaning process [dichotomous score: yes/no]. We will use three prototypes, one per surgeon. The endpoint for each surgeon is failure of the steerable punch before ten cycles or upon completion of ten cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of quality measured by scoring the quality of the remaining rim by two independent experts using a still of an arthroscopic image after completion of the meniscectomy showing the full part of the rim that has been treated. Scoring is performed based on the IKDC form meniscus section[17]. Additionally results will be scored Scores the result based on a classification of the IKDCI-IV a. I. Fully smooth and stable meniscal rim b. II. Somewhat rough edges but acceptable c. III. Rough edges, requires refinement d. IV. Failed surgery, needs to be done over 2. Assessment of usability: A. Documentation of the number of errors made by the surgeon (surgical actions) and the scrub nurse ((dis)assembly) when handling the steerable punch based on video recordings with two video cameras in operating room. B. (Dis)assembly time of the steerable punch performed by the scrub nurse in the operating room determined from video footage C. Questionnaire filled out by the surgeon assessing the workload[18] and ergonomic comfort (see attachment F1). D. Questionnaire filled out by the scrub nurse assessing the workload and ergonomic comfort (see attachment F1). E. Questionnaire filled out by the personnel of the sterilization department assessing workload and ergonomic comfort (see attachment F1). 3. Assessment of patient recovery using the IKDC (see attachment F1) 4. Assessment of postoperative complications including postoperative infection assessed at the regular follow-up two and 6 weeks postoperatively using Patient Reported Outcome Measures (PROMs) which are filled out with CASTOR as part of standard follow up of our patients. 5. Assessment of efficiency measured by: A. Time to perform solely the cutting of the meniscus, which is derived from video recording of the arthroscopic images during the operation. B. Number of repetitive actions during solely the cutting of the meniscus, i.e. repetitive reorientation of steerable punch, repetitive | — |
Countries
Netherlands
Outcome results
None listed