Satisfaction and Recovery After Distal Radius Fracture

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818241
• Other study ID #: DRFx STAR
• Status: Recruiting
• Start date: January 12, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Joakim Stromberg, MD, PhD
• Phone: +46768341327
• Email: joakim.stromberg[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
• Signed written consent

Exclusion Criteria:

• Compound injuries
• Open fractures
• Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
• Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
• Reduced mental capacity (e.g. dementia, substance abuse)

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Treatment of fracture by forearm cast
Patient that are not surgically treated for DRF
• Surgical treatment of fracture
Patients that are surgically treated for DRF

Locations

Country	Name	City	State
Sweden	Alingsås Lasarett/ District Hospital	Alingsås
Sweden	Sahlgrenska University Hospital, Department of Hand Therapy	Mölndal	Region Västra Götaland

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported hand function	Patient Rated Wrist Evaluation (PRWE) questionnaire	Every week for three months
Secondary	Day-by-day pain record	Patient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)	Every day for three months
Secondary	Analgesics	Daily record of use of analgesic drugs	Every day for three months
Secondary	Wrist splint usage	Patient reported use of splint and evaluation of its efficacy	Every week for three months