Clinical trial NCT05818241: Satisfaction and Recovery After Distal Radius Fracture
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Distal Radius Fracture
Keywords: wrist function
recovery
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2023-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a distal radius fracture with the inclusion criteria and without the exclusion criteria at the emergency ward are eligible .

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient-reported hand function
timeFrame: Every week for three months
Secondary outcomes:
measure: Day-by-day pain record
timeFrame: Every day for three months
measure: Analgesics
timeFrame: Every day for three months
measure: Wrist splint usage
timeFrame: Every week for three months
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska University Hospital, Department of Hand Therapy
state: Region Västra Götaland
city: Alingsås
country: Sweden
facility: Alingsås Lasarett/ District Hospital
Study officials:
References: