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Clinical Validation of the C-Arm Rotational View (CARV): Study Protocol of a Prospective Randomized Controlled Trial

Clinical Validation of the C-Arm Rotational View (CARV): Study Protocol of a Prospective Randomized Controlled Trial - -

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53223
Enrollment
160
Registered
2023-05-11
Start date
2025-01-08
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotational malalignment

Interventions

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

Sponsors

Chirurgie
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: age

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
-

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026