Therefore, the study goal is to measure quantitative magnitudes and variation of joint stressing forces in vivo during arthroscopic knee surgery.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the magnitude of knee joint stressing force. The
expected end point is the analysis of the magnitude and variation of the joint
stressing forces and the comparison with a theoretical maximum stressing force
to set up a guideline for safe stressing. These safety levels will be used to
implement force feedback in the arthroscopic simulators. As a result, residents
will experience enhanced training, start their first arthroscopy with a higher
competency level, and potentially shorten their learning curve with repeated
simulator training. Eventually, this contributes to an increase of patient
safety and decrease of surgical errors.
Secondary outcome
nvt
Background summary
During arthroscopy of the knee joint, the available joint space is increased by
stressing the lower leg. This way the surgeon has more manoeuvrability to
inspect and navigate throughout the complete knee joint and to perform surgical
treatment. This skill is considered as one of the five important arthroscopic
skills a resident should ideally possess before he/she starts training in the
operating room.
Training of these skills is preferably performed in arthroscopic knee
simulator away from the patient. For adequate realistic training, feedback
should be given to the resident indicating if he or she stays within stressing
limits that prevent damage of knee ligaments. Data on these tolerable joint
stressing forces are unavailable in literature.
Study objective
Therefore, the study goal is to measure quantitative magnitudes and variation
of joint stressing forces in vivo during arthroscopic knee surgery.
Study design
Patients receive an information letter at least four days before surgery and
can decide on participation on the day of surgery. Preparations for the
measurements are done before the patient entering the operating room. During
surgery, synchronized measurements are performed of the stressing force with a
load sensor attached to the surgeon, and video recordings of the lower leg to
determine its posture and of the arthroscopic view.
Study burden and risks
No interventions will take place, the operation will be delayed for a maximum
of 2 minutes and subjects are not disturbed other than to fill out the informed
consent and measurement of their lower leg length and knee instability. There
are no risks for the patients.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients should be scheduled for a routine knee arthroscopy at the daycare centre.
Patients should have an age 18 years or older
Patients should be able to read the patient informatio
Exclusion criteria
Knee arthroscopy that is not performed at the daycare centre
Age lower than 18 years
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 | NL33847.018.10 |