Satisfaction and Recovery After Distal Radius Fracture

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818241
Collaborator
Vastra Gotaland Region (Other)
300
2
14.6
150
10.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Treatment of fracture by forearm cast
  • Procedure: Surgical treatment of fracture

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 12, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Cast

Patients that are conservatively treated (in a cast, either without or with reduction)

Procedure: Surgical treatment of fracture
Patients that are surgically treated for DRF

Surgery

Patients that undergo surgical treatment (regardless of method)

Procedure: Treatment of fracture by forearm cast
Patient that are not surgically treated for DRF
Other Names:
  • casting, conservative treatment
  • Outcome Measures

    Primary Outcome Measures

    1. Patient-reported hand function [Every week for three months]

      Patient Rated Wrist Evaluation (PRWE) questionnaire

    Secondary Outcome Measures

    1. Day-by-day pain record [Every day for three months]

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

    2. Analgesics [Every day for three months]

      Daily record of use of analgesic drugs

    3. Wrist splint usage [Every week for three months]

      Patient reported use of splint and evaluation of its efficacy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital, Department of Hand Therapy Mölndal Region Västra Götaland Sweden
    2 Alingsås Lasarett/ District Hospital Alingsås Sweden

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden
    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joakim Stromberg, senior consultant,, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT05818241
    Other Study ID Numbers:
    • DRFx STAR
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Joakim Stromberg, senior consultant,, Sahlgrenska University Hospital, Sweden
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2023