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Medial Malleolus FractureNCT05573516

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

A study testing Open reduction and internal fixation in people with Medial Malleolus Fracture and Ankle Fractures, run by Kasr El Aini Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Medial Malleolus Fracture, Ankle Fractures
What is being tested?
Open reduction and internal fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteEgypt
Study dates
18 Aug 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ahmed O Sabry, MBBS contact

+201117632926

sniperrifle22@gmail.com

Egypt1 site, 1 recruiting
  • Kasr Al Ainy-Cairo University- Faculty of Medicine

    Cairo, Manial, 11956

    Ahmed O Sabry, MBBS, +201117632926, sniperrifle22@gmail.com

    Recruiting

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Open reduction and internal fixation
Medical subject headings
Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open reduction and internal fixationProcedure or surgery

    unicortical fully threaded 4mm screws will be used as positional screws after completely reducing the fracture

Study groups in NCT05573516
Study groupRoleWhat they receive
Fixation with 4mm lag screwsExperimentalNot described
Receives: Procedure: Open reduction and internal fixation
Fixation with 4mm fully-threaded positional screwsActive comparatorNot described
Receives: Procedure: Open reduction and internal fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AOFAS score

    Measured: 6 wks (this time when the fracture has usually healed and the patients cat bear weight on the limb)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start18 Aug 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573516
Sponsor's protocol ID
AOS12345
Status last verified
Oct 2022
First submitted
5 Oct 2022
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Open reduction and internal fixation in people with Medial Malleolus Fracture and Ankle Fractures, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed O Sabry, MBBS (+201117632926, sniperrifle22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AOFAS score (time frame: 6 wks (this time when the fracture has usually healed and the patients cat bear weight on the limb)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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