Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

Study Overview
=================
Brief Summary
-----------------
The scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. Long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. This study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.

Official Title
-----------------
Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

Conditions
-----------------
Hand, Wrist, Wounds and Injuries

Intervention / Treatment
-----------------
* Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute scaphoid fractures Injury to surgery less than 7 days Only one injured hand Written informed consent to undergo the surgical procedure Patients of either sex aged between 18 and 70 years Exclusion Criteria: Patients with vascular injuried requiring revascularization Concomitant phalanx fractures or other injuries needing immobilization Loss of skin substance requiring grafts or flaps Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: open reduction group<br> | Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance<br>* Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance<br>|
| Experimental: percutaneous group<br> | Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance<br>* Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Mayo wrist scoring system | The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor. | 3 months |