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4D-IRECT Pilot Trial (4 Dimensional - Impairment of posttraumatic forearm Rotation Evaluated with Computed Tomography)

4D-IRECT Pilot Trial (4 Dimensional - Impairment of posttraumatic forearm Rotation Evaluated with Computed Tomography) - 4D-IRECT Pilot Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50506
Enrollment
35
Registered
2018-03-15
Start date
2019-04-12
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Posttraumatic forearm impairment restricted forearm rotation at least three months after injury

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects with posttraumatic forearm impairment: - Patients with a one-sided posttraumatic impairment of forearm pro- and/or supination - Patients are over the age of 16 years - Patients who are willing to give informed consent, Subjects without posttraumatic forearm impairment: - Subjects are over the age of 16 years and - Subjects who are willing to give informed consent

Exclusion criteria

Exclusion criteria: Subjects with posttraumatic forearm impairment: - A history of trauma to both forearms and/or - Not able to understand or give informed consent and/or - Pregnancy, Subjects without posttraumatic forearm impairment: - A history of trauma to one or both forearm(s) - Not able to understand or give informed consent - Pregnancy

Design outcomes

Primary

MeasureTime frame
As an uninjured radius normally rotates +/- 180 degrees around the ulna at the distal radioulnar joint (DRUJ), the aim is to estimate the pattern of restricted motion of the posttraumatic (malunited) radius relative to the ulna, expressed in rotation at the level of the DRUJ. The main endpoint is to study whether we can differentiate between osseous (impinged) versus non-osseous (non-impinged) motion patterns as origin of restricted forearm rotation.

Secondary

MeasureTime frame
Based on the patterns in inter-relational radioulnar motion pattern, the secondary aim is to develop a 4D classification tool for posttraumatic impairment of the forearm and to assess its inter- and intra-observer reliability. Futhermore to assess physiological mechanics of the radioulnar joint and symmetry in motion patterns between two healthy forearms on 4D CT scans.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)