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A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures

Primary Purpose

Medial Malleolus Fracture, Ankle Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open reduction and internal fixation
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Malleolus Fracture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•Displaced medial malleolar fractures (Herscovici type B and C) that can be fixed with screws.

Exclusion Criteria:

  • Open fractures,
  • Age <18 or > 70,
  • Pathological fractures,
  • Patients with DM,
  • Type A and D fractures according to the Herscovici system(As these fractures would require screws to be positioned horizontally),
  • associated tibial plafond fractures

Sites / Locations

  • Kasr Al Ainy-Cairo University- Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fixation with 4mm lag screws

Fixation with 4mm fully-threaded positional screws

Arm Description

Outcomes

Primary Outcome Measures

AOFAS score

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
October 6, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05573516
Brief Title
A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures
Official Title
A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A clinical trial comparing the outcomes of fixation of medial malleolar fractures either by fully threaded uni-cortical 4mm positional screws vs 4mm lag screws.
Detailed Description
Ankle fractures are one of the most common traumatic injuries an orthopedic surgeon encounters during their clinical practice, Hence looking into the best management of them and conducting extensive research to determine the best methods of their fixation would be justifiable. Malleolar fractures and in particular medial malleolar involve the articular surface of the ankle joint and hence a displacement beyond > 2mm requires careful anatomical restoration through open reduction and internal fixation. The medial malleolus is characterized with it's porous cancellous bone, and hence a lack of a secure fixation method is a major issue and is responsible for post-operative complication and delayed healing. The AO recommends fixation of these fractures with 4mm partially threaded lag screws. Some studies have arisen that may challenge this AO philosophy and raise the question if this actually is the best choice of treatment for medial malleolar fractures. The problem with lag screws is that they have a higher chance of unravelling. and other studies have shown that constructs fixated with fully threaded screws provide higher stability and provides higher shear resistanceand a higher pull-out strength. The other alternative to using a partially threaded lag screw would be a fully threaded lag screw of virtually the same length however it would act as a positional screw and hence the fracture displacement must be perfectly reduced with bone reduction forceps before inserting the fully threaded screws to achieve their property as positional screws. A study conducted by parker et al. comparing the use of partially threaded and positional(fully threaded) screws of the same length found that compression force was in favor of the fully threaded screws. This could be due to threads of the fully threaded screws obtaining purchase in the dense physeal scar area while in the partially threaded screw, the threads bypass this physeal scar. Despite all this evidence and the widespread of this fracture among the population, the number of studies comparing lag vs positional screws in medial malleolar fractures is scarce and to our knowledge as of the time of the submission of this study, only a single study was made by Sayyed-Hosseinian et al., was performed as a pilot study comparing both fixation methods, due to the relatively small sample size , it indicates that further clinical trials are necessary to reach a reliable conclusion. The conduction of a clinical trial with a proper sample size should be done to assess if lag screws are actually a superior method to be considered the main recommendation, as the AO suggests, to treat medial malleolar fractures or if alternatively, positional screws are better, as some biomechanical tests mentioned prior have shown. This study will compare both methods to decide the superior fixation method in terms of achieving a better and faster quality of life post-surgery and and the least risk for potential complication for medial malleolar fractures by obtaining the AOFAS, MOXFQ and OMAS scores and comparing complications in both study groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Malleolus Fracture, Ankle Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixation with 4mm lag screws
Arm Type
Experimental
Arm Title
Fixation with 4mm fully-threaded positional screws
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Open reduction and internal fixation
Intervention Description
unicortical fully threaded 4mm screws will be used as positional screws after completely reducing the fracture
Primary Outcome Measure Information:
Title
AOFAS score
Time Frame
6 wks (this time when the fracture has usually healed and the patients cat bear weight on the limb)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: •Displaced medial malleolar fractures (Herscovici type B and C) that can be fixed with screws. Exclusion Criteria: Open fractures, Age <18 or > 70, Pathological fractures, Patients with DM, Type A and D fractures according to the Herscovici system(As these fractures would require screws to be positioned horizontally), associated tibial plafond fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed O Sabry, MBBS
Phone
+201117632926
Email
sniperrifle22@gmail.com
Facility Information:
Facility Name
Kasr Al Ainy-Cairo University- Faculty of Medicine
City
Cairo
State/Province
Manial
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed O Sabry, MBBS
Phone
+201117632926
Email
sniperrifle22@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures

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