Driving safely following total hip arthroplasty through an direct anterior approach: investigating brake force and brake response time.

Driving safely following total hip arthroplasty through an direct anterior approach: investigating brake force and brake response time. - The DRIFTH study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52072

Enrollment

154

Registered

2021-09-09

Start date

2021-10-26

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

total hip arthroplasty / hip replacement

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age above 18 years - Male or female - Left THA or right THA - In possession of a valid Category B driving license Healthy subjects: - Age above 50, to match the patient study population - In possession of a valid Category B driving license

Exclusion criteria

Exclusion criteria: - Illiteracy or insufficient command of the Dutch language - Chronic opioid consumption, based on the medication list in the EPD which will be verified when the surgery is scheduled. - Neurological disorders which affect response time (e.g. Parkinson*s disease, MS) -

Design outcomes

Primary

Measure	Time frame
The main study endpoint is brake force at six weeks, determined by means of a pedal force meter in a driving simulator. To answer the research question, postoperative measurements will be compared to preoperative median value.	—

Secondary

Measure	Time frame
Secondary study endpoints are: - Brake response time, using a pressure sensor on the brake pedal. - Brake response time and brake force on the clutch pedal, using the same pedal force meter and pressure sensor. - Subjective ability to drive, determined by means of a questionnaire that is filled out before and after each measurement session. - Repeatability of the driving simulator, using a pressure sensor and a pedal force meter. - Opioid use (type and dosage) at each measurement point.	—

Measure

Time frame

Secondary study endpoints are: - Brake response time, using a pressure sensor on the brake pedal. - Brake response time and brake force on the clutch pedal, using the same pedal force meter and pressure sensor. - Subjective ability to drive, determined by means of a questionnaire that is filled out before and after each measurement session. - Repeatability of the driving simulator, using a pressure sensor and a pedal force meter. - Opioid use (type and dosage) at each measurement point.

—

Countries

Netherlands

Outcome results