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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

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
NA
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
Trial website
Trial related presentations / publications
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
n.j.bleeker@umcg.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05459038