Satisfaction and Recovery After Distal Radius Fracture

NCT ID: NCT05818241

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-12

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Distal Radius Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cast

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

Surgical treatment of fracture

Intervention Type PROCEDURE

Patients that are surgically treated for DRF

Surgery

Patients that undergo surgical treatment (regardless of method)

Treatment of fracture by forearm cast

Intervention Type PROCEDURE

Patient that are not surgically treated for DRF

Interventions

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Treatment of fracture by forearm cast

Patient that are not surgically treated for DRF

Intervention Type PROCEDURE

Surgical treatment of fracture

Patients that are surgically treated for DRF

Intervention Type PROCEDURE

Other Intervention Names

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casting, conservative treatment

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joakim Stromberg

senior consultant,

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sahlgrenska University Hospital, Department of Hand Therapy

Mölndal, Region Västra Götaland, Sweden

Site Status RECRUITING

Alingsås Lasarett/ District Hospital

Alingsås, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Sweden

Central Contacts

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Joakim Stromberg, MD, PhD

Role: CONTACT

+46768341327

Ingrid Andreasson, PhD

Role: CONTACT

+46313421000

Facility Contacts

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Ingrid Andreasson, PhD

Role: primary

+46313421000

Joakim Strömberg

Role: primary

Other Identifiers

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DRFx STAR

Identifier Type: -

Identifier Source: org_study_id

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