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Clinical Trials/NCT07447336
NCT07447336
Not yet recruiting
Not Applicable

Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study

Sohag University1 site in 1 country52 target enrollmentStarted: March 5, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
52
Locations
1
Primary Endpoint
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

Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • neuropathic disorders
  • paralytic disorders
  • 5 Osteoporotic fractures
  • Patients with uncontrolled diabetes
  • 7 Comminuted fractures

Arms & Interventions

Group (A) : plate fixation for lateral malleolus fracture

Active Comparator

fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate(Group A) versus intramedullary screw fixation (Group B)

Intervention: Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation (Procedure)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Hemdan

Resident at Orthopaedics and Trauma department Sohag University Hospitals

Sohag University

Study Sites (1)

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