Faculty of Medecine ,Sohag University
Sohag, Egypt
Not Yet Recruiting
NCT Number: NCT07447336
Plate Versus Intramedullary Screw for Lateral Malleolus Fracture in Ankle Fracture Type A&B
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this 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 will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- Associated syndesmotic injury
- 2open fractures 3. neuropathic disorders 4. paralytic disorders
- 5 Osteoporotic fractures 6. Patients with uncontrolled diabetes
- 7 Comminuted fractures
Treatment and study plan
Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
Procedureunder 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
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sohag University
Other
Registry information
Official study title
Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Mar 3, 2026
- Registry last updated
- Mar 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.