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NCT Number: NCT05818241

Satisfaction and Recovery After Distal Radius Fracture

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital, Department of Hand Therapy, Mölndal, Region Västra Götaland, Sweden

Loading trial locations.

About this study

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:

  • Pain (day-by-day registration on a Likert scale, range 0-10)
  • Analgesic used (day-by-day registration of specific drug, dose and number)
  • PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
  • Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treatment of fracture by forearm cast

Procedure

Patient that are not surgically treated for DRF

Other names: casting, conservative treatment

Surgical treatment of fracture

Procedure

Patients that are surgically treated for DRF

Primary outcomes

  1. Patient-reported hand function

    Time frame: Every week for three months

    Patient Rated Wrist Evaluation (PRWE) questionnaire

Secondary outcomes

  1. Day-by-day pain record

    Time frame: Every day for three months

    Patient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)

  2. Analgesics

    Time frame: Every day for three months

    Daily record of use of analgesic drugs

  3. Wrist splint usage

    Time frame: Every week for three months

    Patient reported use of splint and evaluation of its efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Andreasson, PhD

CONTACT

[email protected]

+46313421000

Joakim Stromberg, MD, PhD

CONTACT

[email protected]

+46768341327

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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