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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
Scientific title
Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.
Secondary ID [1] 0 0
81191
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures 0 0
Surgery 0 0
Complication,Postoperative 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rotational (mal)alignment
Timepoint [1] 0 0
Up to 12 months after initial surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* The following exclusion criteria will be used: age <18 years, fractures not suitable for IMN and pathological fractures.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre, Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
University Medical Center Groningen
Address
Country

Ethics approval
Ethics application status

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?
Trial website
https://clinicaltrials.gov/study/NCT05459038
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nils Jan Bleeker, MD
Address 0 0
Country 0 0
Phone 0 0
050 361 6161
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05459038