Rapid Prototyping in Clavicle Fracture Treatment

When a midshaft clavicle fracture (group I in Alman classification [1]) is
treated surgically, open reduction and internal fixation (ORIF) is common
practice. The selection of the plate and screw and possible manipulation of the
plate takes place perioperatively, because no preoperative method is available.
These handlings take time and are suboptimal in sterile environment of the OR.
When the patient specific osteosynthetic material is known and present at the
OR and the placement is planned, the surgeon would benefit in a couple ways. No
need to search for the right material or to manipulate the material, the
location of the material on the fracture is known and the drill depths can be
predefined on the drill, which can prevent complications as pneumathoraces and
damage to arteries and nerves. This can result in a shorter fixation time (time
it takes to reposition and fixate the fracture) and a repositioning in a more
anatomical shape of the clavicle, which benefits the patient with lower chance
of infection or discomforts with for example using backpacks.
Using rapid prototyping, in this case a 3D printer, these preparations can be
utilized by printing a patient specific, real size clavicle reconstruction,
reconstructed from a preoperative CT-scan.

Primary Objective:
To determine whether pre-operative planning of the ORIF of group I clavicle
fractures saves time. Predefined periods during surgery/ parts of the surgery
will be monitored and compared with the conventional method.

Hypothesis:
The current handlings time of repositioning and fixating the clavicle is
estimated around 10 minutes. By disregarding the selection and alteration of
the fixation plate the time is to be halved to 5 minutes.

Secondary Objective:
To assess if when the surgery planned pre-operatively, the workflow during the
surgery will improve.

The proposed study concerns a controlled, prospective, non-blinded clinical
trial. The study will last 4 months and during this period every patient that
presents itself at Isala Klinieken Zwolle with a group I fractured clavicle and
an indication for surgery will be evaluated for inclusion until the quota is
reached. If the quota is not reached in this period it will be stretched (and
notified to the METC)
The results will be compared with an ongoing status study with the same
parameters in the conventional procedure.

When patients are included at Isala Klinieken Zwolle and have given their
consent, they will be planned for CT scan immediately. Besides this scan no
differing interventions or expectations are asked of the patient in contrast to
the conventional procedure. Within the same time span the patient is planned
for surgery, usual around a week after the decision for surgery is made.

The subjects receive a preoperative CT-scan followed by ORIF, pre-planned based
on a physical model of the clavicle, reconstructed from this CT-scan. This
takes place in the same timeframe as a standard ORIF procedure.

The burden and risks come with the extra CT scan, which is an extra appointment
and radiation exposure. But if the hypothesis is correct the surgery will be
less radical.