Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05459038
Registration number
NCT05459038
Ethics application status
Date submitted
5/04/2022
Date registered
14/07/2022
Date last updated
14/07/2022
Titles & IDs
Public title
Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.
Query!
Scientific title
Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.
Query!
Secondary ID [1]
0
0
81191
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures
0
0
Query!
Surgery
0
0
Query!
Complication,Postoperative
0
0
Query!
Condition category
Condition code
Surgery
0
0
0
0
Query!
Other surgery
Query!
Injuries and Accidents
0
0
0
0
Query!
Fractures
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - C-Arm Rotational View (CARV)
Experimental: Interventional group - Patients assigned to the interventional group will undergo an identical surgical procedure as patients assigned to the control group. The only difference with the control group is that tibial alignment will be obtained according to the standardized CARV-protocol.
No Intervention: Control group - Patients assigned to the control group will undergo an identical surgical procedure as patients assigned to the interventional group. The only difference with the intervention group is that tibial alignment will be obtained according to present unstandardized clinical standards
Diagnosis / Prognosis: C-Arm Rotational View (CARV)
CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rotational (mal)alignment
Query!
Assessment method [1]
0
0
Determine the incidence of RM using postoperative CT-assessment. In literature, RM is defined as a rotation =10 degrees relative to the contralateral side. However, considering the physiological left-right difference of 4 degrees between left and right-sided tibiae, with right-sided tibiae on average 4 degrees more externally rotated, RM is defined as malrotation of < -6 degrees or >14 degrees in right-sided tibiae and < -14 degrees or >6 degrees in left-sided tibiae. A negative angle represents internal rotation and positive angle external rotation.
Query!
Timepoint [1]
0
0
Up to 12 months after initial surgery
Query!
Eligibility
Key inclusion criteria
- All consecutive patients (=18 years) with an open or closed tibia shaft fracture, who
are eligible for IMN, will be asked to enroll in the study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- The following exclusion criteria will be used: age <18 years, fractures not suitable
for IMN and pathological fractures.
Query!
Study design
Purpose of the study
Supportive Care
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/09/2022
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Flinders Medical Centre, Flinders University - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
Netherlands
Query!
State/province [1]
0
0
Groningen
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University Medical Center Groningen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In
the USA, a total of 492.000 tibial fractures were reported per year by the National Center of
Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft
fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a
prevalence up to 30%.
From a clinical point of view, there is limited knowledge on how to avoid RM during IMN.
Clinical estimation of tibial alignment is difficult, resulting frequently in RM following
IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed
after surgery when the opportunity for direct revision has passed. Both difficulties in
intraoperative clinical judgement of tibial alignment as well as postoperative detection of
RM when the possibility for direct revision has passed, do support the need for an
easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of
tibial shaft fractures.
Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View
(CARV)' was determined in order to improve the accuracy of alignment control during IMN of
tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side
to correct for rotational malalignment of the injured side in which the rotation of the C-Arm
Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM
following IMN of tibia fractures. However, a prospective trial is needed to determine the
performance of CARV in clinical practice. Therefore, a prospective multi-center randomized
controlled trial is designed to assess the clinical feasibility and potential benefits of the
CARV-protocol. The following primary research question was defined: can the risk for RM
following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05459038
Query!
Trial related presentations / publications
Theriault B, Turgeon AF, Pelet S. Functional impact of tibial malrotation following intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2012 Nov 21;94(22):2033-9. doi: 10.2106/JBJS.K.00859.
Cain ME, Hendrickx LAM, Bleeker NJ, Lambers KTA, Doornberg JN, Jaarsma RL. Prevalence of Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures: Can We Reliably Use the Contralateral Uninjured Side as the Reference Standard? J Bone Joint Surg Am. 2020 Apr 1;102(7):582-591. doi: 10.2106/JBJS.19.00731.
Bleeker NJ, Cain M, Rego M, Saarig A, Chan A, Sierevelt I, Doornberg JN, Jaarsma RL. Bilateral Low-Dose Computed Tomography Assessment for Post-Operative Rotational Malalignment After Intramedullary Nailing for Tibial Shaft Fractures: Reliability of a Practical Imaging Technique. Injury. 2018 Oct;49(10):1895-1900. doi: 10.1016/j.injury.2018.07.031. Epub 2018 Jul 29.
Puloski S, Romano C, Buckley R, Powell J. Rotational malalignment of the tibia following reamed intramedullary nail fixation. J Orthop Trauma. 2004 Aug;18(7):397-402. doi: 10.1097/00005131-200408000-00001.
Bleeker NJ, Reininga IHF, van de Wall BJM, Hendrickx LAM, Beeres FJP, Duis KT, Doornberg JN, Jaarsma RL, Kerkhoffs GMMJ, IJpma FFA. Difference in Pain, Complication Rates, and Clinical Outcomes After Suprapatellar Versus Infrapatellar Nailing for Tibia Fractures? A Systematic Review of 1447 Patients. J Orthop Trauma. 2021 Aug 1;35(8):391-400. doi: 10.1097/BOT.0000000000002043.
Shih YC, Chau MM, Arendt EA, Novacheck TF. Measuring Lower Extremity Rotational Alignment: A Review of Methods and Case Studies of Clinical Applications. J Bone Joint Surg Am. 2020 Feb 19;102(4):343-356. doi: 10.2106/JBJS.18.01115. No abstract available.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Nils Jan Bleeker, MD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
050 361 6161
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05459038
Download to PDF