- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276334
Same Day Discharge Vs. Hospitalization for Operative Fixation of Distal Radius Fractures
Outpatient vs. Inpatient Surgery for Distal Radius Fractures: A Prospective Randomized Trial
The goal of this clinical trial is to examine the results for same-day discharge after distal radius operative fixation in adult pupolation. The main questions it aims to answer are:
Is same day discharge safe and effective for distal radius fractures? Are the functional and patient reported outcome measures results different between same day discharge and hospitalized patients? Researchers will compare same day discharge patients with jospitalized patients to see if there are any differences between the groups
Participants will:
- undergo surgery
- atend outpatient clinical follow up visits
- answer dedicated questioneres
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Israel
-
Ẕerifin, Israel, Israel
- Shamir Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged ≥18 years and
- diagnosed with a DRF requiring surgical intervention and
- booked for surgery
Exclusion Criteria:
- Refusal to participate in the study
- lack of follow-up
- incomplete clinical or radiologic documentation
- significant cardiac or pulmonary comorbidities
- inadequate social support at home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Same-day-discharge
|
Same day discharge of patients undergoing distal radius operative fixation
|
|
Active Comparator: Hospitalized
|
release of patients one day after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire,
Time Frame: from surgery to one year after
|
A self-report tool (0-100) measuring upper limb function, where higher scores mean more disability,
|
from surgery to one year after
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ASF-25-0106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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