- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07039695
- Original Trial
Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
Study Overview
Status
Intervention / Treatment
Detailed Description
Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.
Nonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.
A scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo
-
Helwan, Cairo, Egypt, 11795
- Helwan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of a patient is between 20 years to 50 years.
- Non-union or delayed union scaphoid wrist fracture (more than 3 months).
- Closed fracture.
- Patients without previous scaphoid surgery.
- Patients without abnormal renal and/or liver functions.
- Patients without hypocalcemia and/or vitamin D3 deficiency.
Exclusion Criteria:
- Open fracture.
- Patients with proximal or distal fracture of the scaphoid.
- Patients with avascular necrosis of scaphoid.
- Patients with mid-carpal arthritis or pan-carpal arthritis.
- Patients with carpal instability.
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: Volar buttress plate group
Patients will be treated by a volar buttress plate.
|
Patients will be treated by a volar buttress plate.
|
|
Experimental: Herbert screw group
Patients will be treated by Herbert screw.
|
Patients will be treated by Herbert screw.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mayo Wrist Score
Time Frame: 3 months post-procedure
|
The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength.
Mayo Wrist Score ranges from 0 to 100.
Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.
|
3 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time Frame: 3 months post-procedure
|
The Disabilities of the Arm, Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity.
The score is calculated on a scale score ranging from 0 (no disability) to 100 (most severe disability).
|
3 months post-procedure
|
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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