To assess whether the application of CARV for intra-medullary nailing of tibial shaft fractures results in a more accurate rotationalalignment of the tibia in comparison to conventional (e.g., eyeballing of the surgeon according to current practice…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the degree of rotation of the nailed tibia (with the
contralateral leg as a reference) as measured on a
postoperative CT-scan.
Secondary outcome
-
Background summary
Rotational malalignment of the tibia occurs in up to 40% of cases after
intramedullary-nailing of tibial shaft fractures. The aim of
this study is to assess the clinical feasibility of a new introduced
standardized intraoperative fluoroscopy protocol coined *C-Arm
Rotational View (CARV)* in order to reduce the risk of rotational malalignment
during intramedullary-nailing of tibial shaft
fractures. The CARV includes predefined fluoroscopy landmark-views of the
uninjured side to obtain correct alignment of the
injured side with use of the rotation of the C-arm.
Study objective
To assess whether the application of CARV for intra-medullary nailing of tibial
shaft fractures results in a more accurate rotational
alignment of the tibia in comparison to conventional (e.g., eyeballing of the
surgeon according to current practice) alignment of
the tibia during intra-medullary nailing of tibial shaft fractures.
Study design
RCT
Intervention
patients assigned to the intervention group will be treated according to the
local guidelines with intramedullary-nailing for a tibial
shaft fracture in which alignment of the tibia is guided by the *C-Arm
Rotational View* (CARV).
Study burden and risks
The extent of burden and risks for patients participating in the study is
considered low, because the operative procedure itself
won*t change. Moreover, our pilot study with application of CARV for nailing of
tibial shaft fractures (N=5) demonstrated that this
technique is feasible, safe and appears to be effective. With the outcome of
this study, we intend to present the results at
international conferences and publish them in international peer-reviewed
journals.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: all consecutive
patients (>=18 years) with an open or closed tibial shaft fracture, who are
eligible for intramedullary-nailing, will be
asked to enroll in the study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: age <18 years, fractures not suitable for
intramedullary-nailing, medical history of a tibial shaft fracture, bilateral
tibial shaft fractures, pathological fractures or when CARV could not be
performed due to concomitant fractures.
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 |
|---|---|
| ClinicalTrials.gov | NCT05459038 |
| CCMO | NL84303.042.23 |