Medial MalleolusNCT06883435
Percutaneous Cannulated Screws Versus Open Reduction and Internal Fixation in the Treatment of Displaced Isolated Medial Malleolar Fractures in Adults
A study testing closed reduction and percutaneous fixation of medial malleolus and open reduction and screw fixation of medial malleolus in people with Medial Malleolus, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Medial Malleolus
- What is being tested?
- closed reduction and percutaneous fixation of medial malleolus and open reduction and screw fixation of medial malleolus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Apr 2023
- 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
- adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.
Who cannot join
- comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures
The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.
Read the detailed description
Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.
MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.
When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.
Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.
In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.
There is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.
- Conditions
- Medial Malleolus
- Being tested
- closed reduction and percutaneous fixation of medial malleolus, open reduction and screw fixation of medial malleolus
- Keywords
- Isolated medial malleolar fractures, Displaced, Percutaneous fixation, open reduction, Cannulated screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed reduction and percutaneous fixation of medial malleolusProcedure or surgery
No incision is made for fracture reduction, a pointed reduction clamp is applied to reduce the fracture, two 4 mm partially threaded cannulated cancellous screws are inserted over guide wires through stab incisions. Fluoroscopy is used to assess reduction.
open reduction and screw fixation of medial malleolusProcedure or surgery
An incision is made over the fracture; the MM fracture is reduced under direct vision. fixation is performed with two 4mm cannulated partially threaded cancellous screws. fluoroscopy is used to confirm reduction.
| Study group | Role | What they receive |
|---|---|---|
| closed reduction and percutaneous fixation (CRPF) | Experimental | percutaneous cannulated screws fixation of medial malleolus Receives: Procedure: closed reduction and percutaneous fixation of medial malleolus |
| open reduction and internal fixation (ORIF) | Experimental | Open reduction and screw fixation of medial malleolus Receives: Procedure: open reduction and screw fixation of medial malleolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS (American association of foot and ankle society) ankle-hind foot score
American association foot and ankle society score for foot and ankle conditions
Measured: Baseline
Secondary outcomes (2)
Foot and ankle ability measure (FAAM)
Patient reported outcome measure for foot and ankle condition
Measured: baseline
visual analogue scale (VAS)
method of pain assessment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Apr 2021
- Primary completion3 Mar 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medial MalleolusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalaf fathy elsayed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883435
- Sponsor's protocol ID
- Soh-Med-23-03-09PD
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahmed KFE. Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial. Arch Orthop Trauma Surg. 2025 Jul 25;145(1):385. doi: 10.1007/s00402-025-06000-w.
PubMed 40711571
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures
- ClinicalTrials.gov ID
- NCT06883435
- Acronym / sponsor ID
- Soh-Med-23-03-09PD
- Conditions
- Medial Malleolus
- Keywords
- Isolated medial malleolar fractures, Displaced, Percutaneous fixation, open reduction, Cannulated screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 19 Mar 2025 (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.
The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.
Detailed description
Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.
MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.
When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.
Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.
In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.
There is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed reduction and percutaneous fixation (CRPF) | Experimental | Procedure: closed reduction and percutaneous fixation of medial malleoluspercutaneous cannulated screws fixation of medial malleolus |
| open reduction and internal fixation (ORIF) | Experimental | Procedure: open reduction and screw fixation of medial malleolusOpen reduction and screw fixation of medial malleolus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.
Key exclusion criteria (1 listed)
- comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.
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 |
|---|---|---|
| closed reduction and percutaneous fixation of medial malleolusNo incision is made for fracture reduction, a pointed reduction clamp is applied to reduce the fracture, two 4 mm partially threaded cannulated cancellous screws are inserted over guide wires through stab incisions. Fluoroscopy is used to assess reduction. | Procedure or surgery | closed reduction and percutaneous fixation (CRPF) |
| open reduction and screw fixation of medial malleolusAn incision is made over the fracture; the MM fracture is reduced under direct vision. fixation is performed with two 4mm cannulated partially threaded cancellous screws. fluoroscopy is used to confirm reduction. | Procedure or surgery | open reduction and internal fixation (ORIF) |
Primary outcome
AOFAS (American association of foot and ankle society) ankle-hind foot score
Time frame: Baseline
American association foot and ankle society score for foot and ankle conditions
2 secondary outcomes
Foot and ankle ability measure (FAAM)
Time frame: baseline
visual analogue scale (VAS)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 40711571Ahmed KFE. Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial. Arch Orthop Trauma Surg. 2025 Jul 25;145(1):385. doi: 10.1007/s00402-025-06000-w.
- Individual participant dataSharing planned: Undecided
Related trials for Medial Malleolus
Not yet recruiting
IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA
Revision Total Knee Arthroplasty
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Fixation of Medial Malleolar Fractures .
Anterograde Screw Fixation for Medial Malleolus Fractures
Recruiting
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Ankle Fractures, Ankle Fracture - Lateral Malleolus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed reduction and percutaneous fixation of medial malleolus and open reduction and screw fixation of medial malleolus in people with Medial Malleolus, run by Sohag University 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 1 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: finished, as of the sponsor's last update on 19 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS (American association of foot and ankle society) ankle-hind foot score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883435, which also lists 1 linked publication.
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 19 Mar 2025.