The main objective of this study is to assess the safety, efficiency, and quality of the steerable punch for future CE-marking
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 grasping of meniscal
tissue before cutting, reinsertion of steerable punch, repetitive adjusting
grip without performing a goal-oriented action
Background summary
The menisci are responsible for resorbing 50-70% of the load across the knee
compartment. The most common cause of meniscal injury are traumatic injuries in
younger adults and degeneration in older adults. When the meniscus is torn, the
loading in the knee is disturbed resulting in complaints such as pain, swelling
and clicking. In a minimally invasive surgical procedure (meniscectomy), the
torn part is cut with a slender rigid cutting instruments (punches). The
rigidity in combination with the tightness and curvature of the knee joint
gives limitations in reaching the tear, optimal surgical workflow and quality
of the cut. The newly developed steerable punch having a sideways steerable
instrument tip solves these limitations. To allow market entry of this surgical
instrument ,evidence needs to be collected showing its compliance with the
medical devices safety regulations.
Study objective
The main objective of this study is to assess the safety, efficiency, and
quality of the steerable punch for future CE-marking
Study design
Case series
Intervention
Routine meniscectomy procedure with the steerable punch instead of ordinary
punches.
Study burden and risks
The benefit for the patients can be a shorter operation time, thus a shorter
period of anaesthetics, less risk on overloading of the access portals or
cartilage and a more smooth stable meniscal rim that enhances recovery.
Finally, the surgical workflow is optimized which induces less risk of
unintended damage.
The main potential risk (a full risk analysis can be found in the IMDD)
is peroperative breakage of a part of the tip of the steerable punch. In a
previous submitted cadaver study, breakage of these parts did not occur [18].
In this 0-series prototype, utmost care is taken to even further strengthen the
weakest parts and prevent this. Furthermore, the steerable punch is designed
such that if the weakest parts break, the broken part is sized such that it can
be grasped and taken out the knee joint. Subsequently, the surgical procedure
can be continued with normal punches. Therefore, we assume the risk is minimal
for the patient, but with the benefit of receiving a high quality and efficient
surgical procedure.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 16 years or older;
- diagnosed with a traumatic meniscal tear;
- scheduled for an operation to cut the traumatic meniscal tear.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63171.018.18 |