Plate Versus Intramedullary Screw for Lateral Malleolus Fracture in Ankle Fracture Type A&B
Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
Study Overview
Status
Conditions
Detailed Description
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Mohamed Hemdan, Principal investigator
- Phone Number: +201140113008
- Email: ahmadmohdelrashedy@gmail.com
Study Locations
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Sohag, Egypt
- Faculty of Medecine ,Sohag University
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Contact:
- Ahmed Mohamed Hemdan, Principal investigator
- Phone Number: +201140113008
- Email: ahmadmohdelrashedy@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Displaced , unstable lateral malleolar fractures Weber type A or B,
- either isolated or associated with medial or posterior malleolar fractures .
- Age group : [18_60 years old Patients]
- Male or female patient
Exclusion Criteria:
1. Associated syndesmotic injury
- 2open fractures 3. neuropathic disorders 4. paralytic disorders
- 5 Osteoporotic fractures 6. Patients with uncontrolled diabetes
- 7 Comminuted fractures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group (A) : plate fixation for lateral malleolus fracture
fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate(Group A) versus intramedullary screw fixation (Group B)
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under spinal anaesthesia. A suitable broad_spectrum antibiotic will be given with induction of anaesthesia. Patients will be positioned supine on a standard radiolucent operation table, under image intensifier guidance. A pneumatic tourniquet will be placed on the thigh and inflated . Plate fixation group: A straight incision made over the lateral malleolus . Then, blunt dissection through subcutaneous fat made to avoid injury to the superficial peroneal nerve. The periosteum dissected away to allow clean inspection of the fracture fragments. After the fracture reduced, plate applied to the lateral side of the lateral malleolus and held to the bone by a plate holder. The plate secured to the bone by screws above the fracture site and below it . Wounds then closed in layers before adding a sterile gauze dressing. Intramedullary Screw group: Under image intensifier guidance, closed reduction achieved by inverting and internally rotating the foot |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
Time Frame: 4months,6months,9months,1year after treatment
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compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by ORIF and plate fixation versus intramedullary screw fixation .Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants Functional outcome evaluated by Manchester_Oxford Foot Questionnaire(MOXFQ) scoring system: comprises three dimensions (pain, standing/walking, social interaction ) and also by VAS(Visual Analogue score)is a 10-cm ( ) straight line used to measure subjective intensity of pain, fatigue, or mood, with 0 representing "no pain" and 10 or 100 representing "worst imaginable pain" American Orthopaedic Foot and Ankle Society (AOFAS) score is a 100-point clinical rating system (0-100, with higher being better) designed to evaluate pain (40 pts), function (50 pts), and alignment (10 pts) for foot and ankle |
4months,6months,9months,1year after treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- Soh_Med_26_2_2MS
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
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