To assess the accuracy of the screw placements after using a surgical guide in patients operated for intra-articular tibial fractures.
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the accuracy of the screw placement (the difference
between the intended position and the achieved position will be determined in
terms of screw direction in degrees), which will be assessed by matching the
preoperative virtual planning with the post-operative CT images.
Secondary outcome
The secondary endpoint is the residual fracture displacement (in mm), as
measured on the postoperative CT-scan. Additionally, the surgical efficiency in
terms of total time for intra-operative bending manoeuvres, plate positioning
and fixation and the surgeon*s satisfaction about implant handling and
positioning will be assessed.
Background summary
In surgery of intra-articular fractures of the tibia, achieving an optimal
reconstruction of the articular surface improves the functional outcome and
decreases the risk of progressive osteoarthritis and the subsequent need for
total knee arthroplasty or ankle arthrodesis. With the current osteosynthesis
implants it can be difficult to control the direction of the screws. The use of
a surgical guide can help the surgeon achieving the right trajectory of the
screw and therefore aid to a better reconstruction of the articular surface.
Study objective
To assess the accuracy of the screw placements after using a surgical guide in
patients operated for intra-articular tibial fractures.
Study design
All patients who will be included in this feasibility study will be operated
for an intra-articular proximal (tibial plateau) or distal (pilon) tibial
fracture using the standard off-the-shelf osteosynthesis implants with the
assistance of a personalized surgical drill-guide. This creates the opportunity
to pre-determine the screw directions and screw lengths before the surgery. CT
data will be used to create a 3D computer model of the fractured tibia, a
standard implant will be virtually fitted on the 3D model and a personalized
surgical guide will be designed, printed and temporarily fitted on top of the
implant during surgery to aim the drill-bit and subsequently the screws in the
right direction.
In case a patient does not want to be included in this study, he will be
treated according to the current standards in which the operative plan is based
on the pre-operative (2D) CT scan en the length of the screws is determined
during surgery.
Intervention
Not applicable
Study burden and risks
The extent of burden and risks for patients participating in the study is
considered low, because the operative procedure itself will not change. The
surgery and follow-up will be performed according to the standard of care.
Surgical drilling-guides for screw placement are part of the routine treatment
in complex fractures (e.g. pelvis) and other surgical fields such as
maxillo-facial reconstructions in the UMCG. Additionally, screw placement will
be monitored during the operation according to the standard of care by using
intraoperative fluoroscopy to verify the screw directions.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Patients >= 18 years
- Intra-articular fracture of the tibial plateau (AO type 41 B1-3 and C1-3) or
the pilon tibiale (AO type 41 B1-3 and C1-3).
- Indication for surgical treatment of these fractures (as decided by the
treating surgeon according to the standard of care)
- Written informed consent.
Exclusion criteria
- Patients < 18 years at the time of the incident
- Extra-articular fractures
- Pathological fractures
- Pre-existent conditions which affect the knee or ankle function, e.g.
rheumatoid arthritis
- Earlier fractures on the same extremity, which caused persistent functional
impairment.
Design
Recruitment
Medical products/devices used
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 | NL72543.042.20 |