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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy-Cairo University- Faculty of Medicine
Cairo, Manial, 11956
Ahmed O Sabry, MBBS, +201117632926, sniperrifle22@gmail.com
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.
- Conditions
- Medial Malleolus Fracture, Ankle Fractures
- 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 group | Role | What they receive |
|---|---|---|
| Fixation with 4mm lag screws | Experimental | Not described Receives: Procedure: Open reduction and internal fixation |
| Fixation with 4mm fully-threaded positional screws | Active comparator | Not 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.
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.
- First posted10 Oct 2022
- Study start18 Aug 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Malleolus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures
- ClinicalTrials.gov ID
- NCT05573516
- Acronym / sponsor ID
- AOS12345
- Conditions
- Medial Malleolus Fracture, Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation with 4mm lag screws | Experimental | Procedure: Open reduction and internal fixation |
| Fixation with 4mm fully-threaded positional screws | Active comparator | Procedure: Open reduction and internal fixation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Displaced medial malleolar fractures (Herscovici type B and C) that can be fixed with screws.
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction and internal fixationunicortical fully threaded 4mm screws will be used as positional screws after completely reducing the fracture | Procedure or surgery | Fixation with 4mm fully-threaded positional screws, Fixation with 4mm lag screws |
Primary outcome
AOFAS score
Time frame: 6 wks (this time when the fracture has usually healed and the patients cat bear weight on the limb)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.