Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05818241
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-04-05
Brief Title:
Satisfaction and Recovery After Distal Radius Fracture
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Study on the Immediate Recovery and Satisfaction After Distal Radius Fracture During the First Three Months- a PROM Based Observational Study with Day-to-day Records
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Distal radius fracture is the most common fracture in Sweden but little is known about the patients experience of pain and hand function during the first three months after the injury This observational study will provide detailed information on a daily basis regarding pain use of analgesic drugs use of splints and hand function as measured weekly by a condition-specific questionnaire
Detailed Description:
Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months
1 Pain day-by-day registration on a Likert scale range 0-10
2 Analgesic used day-by-day registration of specific drug dose and number
3 PRWE Patient Reported Wrist Evaluation form week-by-week registration
4 Use of and evaluation of efficacy of prefabricated wrist splints week-by-week registration
5 Details of sick leave and return to work at completion of the questionnaire at three months
The study is entirely PROM-based and the patient will not require any additional appointments
1 Pain day-by-day registration on a Likert scale range 0-10
2 Analgesic used day-by-day registration of specific drug dose and number
3 PRWE Patient Reported Wrist Evaluation form week-by-week registration
4 Use of and evaluation of efficacy of prefabricated wrist splints week-by-week registration
5 Details of sick leave and return to work at completion of the questionnaire at three months
The study is entirely PROM-based and the patient will not require any additional appointments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None