- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07697976
DRF Reposition Manual Reduction vs Finger-trap Traction (RepoDRF2)
Unterschied Der Reposition in Bruchspaltanästhesie Zur Reposition im Aushang Bei Einer Distalen Radiusfraktur - Eine Prospektiv Randomisierte Studie
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants have sustained a distal radius fracture treated with cast immobilization. Two common conservative management approaches are being compared: (1) closed reduction under a local anesthetic (hematoma block) followed by traction and casting, and (2) immobilization after traction alone without formal reduction under anesthesia.
While the first method aims to restore anatomical alignment initially, loss of reduction may occur over time. The second method improves alignment but does not attempt full anatomical reduction.
The study hypothesis is that both approaches result in similar wrist alignment and functional outcomes after completion of treatment. The objective of this study is to determine whether reduction under local anesthesia followed by traction provides any advantage over traction alone in patients with distal radius fractures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyrol
-
Innsbruck, Tyrol, Austria, 6020
- Univ.-Klinik für Orthopädie und Traumatologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture
Fracture classification (AO), dorsally displaced:
- A2
- A3
- C1
- C2
- C3
Exclusion Criteria:
- Age under 18 years
- Non-displaced fractures of the radius
- Previous palmar displaced fractures of the radius
- Displacement greater than one shaft width
- Open fractures of the radius
- Bilateral radius fractures
- History of a previous radius fracture
- Inability to provide informed consent due to physical or mental disability
- Unavailability for follow-up examinations (e.g., abroad, polytrauma)
- Lack of full legal capacity
- Alcohol or drug abuse
- Allergy to local anesthetics
- Median nerve irritation
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: R: Manual Reduction
|
Hematoma block 5 mL 2% lidocaine, followed by 15 minutes finger-trap traction and then manual reduction + cast application
|
|
Experimental: A: Finger-trap traction
|
15 minutes finger-trap traction only and then cast application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain difference between the groups
Time Frame: From enrollment (Baseline) to the 12month Follow Up.
|
Comparison of the pain score in the course of the follow ups between the groups.
0= no pain 10 = worst pain (maximal pain)
|
From enrollment (Baseline) to the 12month Follow Up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MHQ Hand Score (Patient reported outcome)
Time Frame: Enrollment until 12 month follow up
|
Difference in functional outcome measured with MHQ (Michigan Hand Outcome Questionaire) between the two groups.
0 points= very poor hand function / maximum impairment; 100 points → optimal hand function, no impairment.
|
Enrollment until 12 month follow up
|
|
PRWE - Patient reported outcome
Time Frame: Enrollment until 12month follow up
|
Difference in functional outcome measured with PRWE (Patient-rated wrist evaluation) between the two groups.
0 points= optimal hand function, no impairment; 100 points → very poor hand function / maximum impairment.
|
Enrollment until 12month follow up
|
|
Grip strength
Time Frame: 12 weeks until 12mo Follow up
|
Difference in grip strength measured with dynanometer between the two groups.
Grip strength is compared to the contralateral non-injured wrist.
|
12 weeks until 12mo Follow up
|
|
Range of motion - functional outcome
Time Frame: 12 weeks until 12 mo follow-up
|
Difference in functional outcome (range of motion) measured with goniometer after treatment between the two groups.
Range of Motion is compared to the contraltaeral non-injured wrist.
|
12 weeks until 12 mo follow-up
|
|
Radiological outcome
Time Frame: Enrollment until 12 month Follow up
|
Difference in radiological outcome between the two groups; especially, dorsal tilt, radial inclination and ulnar variance.
|
Enrollment until 12 month Follow up
|
|
Complications
Time Frame: After treatment until 12 month Follow up
|
Complications between the two groups.
|
After treatment until 12 month Follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RepoDRF2
- AOTrauma Research Austria 2020 (Other Grant/Funding Number: AO Trauma)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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