4D-CT examination to evaluate range of motion obstructions and underlying causes in scheker implants

4D-CT examination to evaluate range of motion obstructions and underlying causes in scheker implants - Quantification of DRUJ implant kinematic performance, 4D-EXTEROUS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51086

Enrollment

Registered

2021-06-21

Start date

2022-01-24

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

DRUJ arthroplasty DRUJ implant Forearm prosthesis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients have undergone unilateral arthroplasty of the DRUJ by use of an Aptis Scheker prosthesis, at least six months after the procedure. - Patients have undergone the procedure at the Academic medical centre, Amsterdam - Patients are over the age of 18 years - Patients are willing to give informed consent

Exclusion criteria

Exclusion criteria: - A history of trauma or injury to the contralateral forearm - Not able to understand or give informed consent - Pregnancy

Design outcomes

Primary

Measure	Time frame
The main study parameters will be the range of motion (ROM, pro-sup and flex-ext), grip strength, patient reported outcome measures (PROM), the position of the radius with respect to the ulna and the position of the axis of rotation. The latter two will act as independent variables in a linear regression to find out if and how they influence the first four parameters. The main study endpoint will be to optimize implant characteristics (size, placement, kinematic behavior) to improve wrist function.	—

Measure

Time frame

The main study parameters will be the range of motion (ROM, pro-sup and flex-ext), grip strength, patient reported outcome measures (PROM), the position of the radius with respect to the ulna and the position of the axis of rotation. The latter two will act as independent variables in a linear regression to find out if and how they influence the first four parameters. The main study endpoint will be to optimize implant characteristics (size, placement, kinematic behavior) to improve wrist function.

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results