Transverse Pinning for Metatarsal FracturesNCT07528092
Transverse Pinning Versus Antegrade Intramedullary Pinning for Neck and Shaft Metatarsal Fractures
A study testing Transverse Pinning for neck and shaft Metatarsal Fractures and Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures in people with Transverse Pinning for Metatarsal Fractures and Versus Antegrade Intramedullary Pinning for Metatarsal Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this prospective randomized controlled clinical trial study is to compare clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transverse Pinning for Metatarsal Fractures, Versus Antegrade Intramedullary Pinning for Metatarsal Fractures
- What is being tested?
- Transverse Pinning for neck and shaft Metatarsal Fractures and Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ⦁ Age ≥ 18 years.
- Both sexes.
- Displaced metatarsal neck or shaft fractures.
- Unstable fracture for which reduction could not be maintained after closed reduction.
- Open fractures
Who cannot join
- ⦁ Fractures combined with Lisfranc injury.
- Other concomitant fractures.
- Non displaced fracture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, 82511
alaa Abdelrahman Abdelrasheed, +201016878101, alaa_abdelrahman_post@med.sohag.edu.eg
About this study
The aim of this prospective randomized controlled clinical trial study is to compare clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures
Read the detailed description
Metatarsal fractures account for 35% of fractures of the foot and 5% of all skeletal fractures. They may be single or multiple, and isolated or associated with ligament lesions around the tarsometatarsal joint or with other fractures (1).
Metatarsal fractures result from low-energy trauma in almost 85% of cases. Crush injury accounts for 41% of high-energy foot trauma. Fatigue fracture of metatarsals account for 38% of all fatigue fractures. The second and third metatarsals (M2, M3) are the most affected (2). The fifth metatarsal is involved in up to 70% of metatarsal fractures and approximately 80% of these are proximal (3).
The overall aim of treatment is to restore the alignment of the metatarsals thereby maintaining the longitudinal and transverse arches of the forefoot. This allows normal weight distribution under the metatarsal heads. Nondisplaced fractures and fractures of the second to fourth metatarsals with displacement in the axial plane can be treated conservatively with protected weight bearing in a hard-soled shoe or boot for 4-6 weeks.
Several surgical methods have been introduced to treat displaced fractures when satisfactory reduction and stability cannot be obtained by closed reduction techniques. Among the various surgical techniques available for the fixation of metatarsal fractures, include open reduction internal fixation by screw or mini plate , transverse pinning and antegrade intramedullary pinning Transverse pinning and antegrade intramedullary pinning have gained widespread acceptance due to their minimally invasive stabilization of metatarsal fractures to enable adequate fracture healing in a correct position to restore anatomy and biomechanics of the foot (4).
Antegrade intramedullary pinning technique using Kirschner wire (K-wire) allowed displaced metatarsal fractures to be easily reduced without opening the fracture site, and at the same time secured firm fixation without infringing the metatarsophalangeal (MTP) joint. Furthermore, the described method allowed immediate joint motion and caused no motion or pain limitation, and thus allowed rapid return to daily activities (5).
The purpose of this study will be to compare the clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures.
- Conditions
- Transverse Pinning for Metatarsal Fractures, Versus Antegrade Intramedullary Pinning for Metatarsal Fractures
- Being tested
- Transverse Pinning for neck and shaft Metatarsal Fractures, Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures
- Keywords
- neck and shaft Metatarsal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Pinning for neck and shaft Metatarsal FracturesProcedure or surgery
⦁ Transverse Pinning Under spinal anaesthesia, the patient will be placed in the supine position. Under the guidance of an image intensifier, gentle longitudinal traction will be applied and percutaneous manipulation will be done using k wires and digital pressure.
Antegrade Intramedullary Pinning for neck and shaft Metatarsal FracturesProcedure or surgery
Antegrade Intramedullary Pinning Under spinal anesthesia, the patient will be placed in the supine position. Under guidance of an image intensifier, a small incision will be made over the dorsal aspect of the foot at the proximal end of the fractured metatarsal. Soft tissue will be dissected, taking care not to injure neurovascular structures and extensor tendons. An entry hole will be then made with a 2.0-mm drill bit. A 1.6-mm K-wire will be prepared with distal end bent through 5 and the prepared K-wire will be held by T-handle. The K-wire will be inserted through the entry hole and will be advanced to the medullary canal
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | ⦁ Group A: 20 patients who will be treated by transverse pinning for neck or shaft metatarsal fractures Receives: Procedure: Transverse Pinning for neck and shaft Metatarsal Fractures |
| group B | Active comparator | ⦁ Group B: 20 patients who will be treated by antegrade intramedullary pinning for neck or shaft metatarsal fractures. Receives: Procedure: Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
⦁ Time to bone union
Immediate motion of the MTP joint and partial weightbearing in a stiff-soled shoe will be allowed. full weightbearing will be permitted 4 weeks after the operation.
K-wires will be removed when pain subsided, which will be usually at 6 to 8 weeks for metatarsal head or neck fractures. For metatarsal shaft fractures, K-wires will be removed 3 months after the operation. union will be confirmed in radiographs taken at 12 weeks. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.
Measured: 12 weeks
Secondary outcomes (3)
⦁ Foot function using the Foot and Ankle Ability Measure (FAAM)
Foot function will be evaluated by the Foot and Ankle Ability Measure (FAAM
Measured: 6 months
⦁ Pain intensity using the visual analog scale (VAS)
Pain intensity will be assessed using the Pain intensity using the visual analog scale (VAS).
(0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 6 months
⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse Pinning for Metatarsal FracturesStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelrahman Abdelrasheed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528092
- Sponsor's protocol ID
- soh-med-26-1-5MS
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Pinning Versus Antegrade Intramedullary Pinning for Neck and Shaft Metatarsal Fractures
- ClinicalTrials.gov ID
- NCT07528092
- Acronym / sponsor ID
- soh-med-26-1-5MS
- Conditions
- Transverse Pinning for Metatarsal Fractures, Versus Antegrade Intramedullary Pinning for Metatarsal Fractures
- Keywords
- neck and shaft Metatarsal Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Apr 2026 (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 clinical trial study is to compare clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures
Detailed description
Metatarsal fractures account for 35% of fractures of the foot and 5% of all skeletal fractures. They may be single or multiple, and isolated or associated with ligament lesions around the tarsometatarsal joint or with other fractures (1).
Metatarsal fractures result from low-energy trauma in almost 85% of cases. Crush injury accounts for 41% of high-energy foot trauma. Fatigue fracture of metatarsals account for 38% of all fatigue fractures. The second and third metatarsals (M2, M3) are the most affected (2). The fifth metatarsal is involved in up to 70% of metatarsal fractures and approximately 80% of these are proximal (3).
The overall aim of treatment is to restore the alignment of the metatarsals thereby maintaining the longitudinal and transverse arches of the forefoot. This allows normal weight distribution under the metatarsal heads. Nondisplaced fractures and fractures of the second to fourth metatarsals with displacement in the axial plane can be treated conservatively with protected weight bearing in a hard-soled shoe or boot for 4-6 weeks.
Several surgical methods have been introduced to treat displaced fractures when satisfactory reduction and stability cannot be obtained by closed reduction techniques. Among the various surgical techniques available for the fixation of metatarsal fractures, include open reduction internal fixation by screw or mini plate , transverse pinning and antegrade intramedullary pinning Transverse pinning and antegrade intramedullary pinning have gained widespread acceptance due to their minimally invasive stabilization of metatarsal fractures to enable adequate fracture healing in a correct position to restore anatomy and biomechanics of the foot (4).
Antegrade intramedullary pinning technique using Kirschner wire (K-wire) allowed displaced metatarsal fractures to be easily reduced without opening the fracture site, and at the same time secured firm fixation without infringing the metatarsophalangeal (MTP) joint. Furthermore, the described method allowed immediate joint motion and caused no motion or pain limitation, and thus allowed rapid return to daily activities (5).
The purpose of this study will be to compare the clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Transverse Pinning for neck and shaft Metatarsal Fractures⦁ Group A: 20 patients who will be treated by transverse pinning for neck or shaft metatarsal fractures |
| group B | Active comparator | Procedure: Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures⦁ Group B: 20 patients who will be treated by antegrade intramedullary pinning for neck or shaft metatarsal fractures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ⦁ Age ≥ 18 years.
Key exclusion criteria (3 listed)
- ⦁ Fractures combined with Lisfranc injury.
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 |
|---|---|---|
| Transverse Pinning for neck and shaft Metatarsal Fractures⦁ Transverse Pinning Under spinal anaesthesia, the patient will be placed in the supine position. Under the guidance of an image intensifier, gentle longitudinal traction will be applied and percutaneous manipulation will be done using k wires and digital pressure. | Procedure or surgery | group A |
| Antegrade Intramedullary Pinning for neck and shaft Metatarsal FracturesAntegrade Intramedullary Pinning Under spinal anesthesia, the patient will be placed in the supine position. Under guidance of an image intensifier, a small incision will be made over the dorsal aspect of the foot at the proximal end of the fractured metatarsal. Soft tissue will be dissected, taking care not to injure neurovascular structures and extensor tendons. An entry hole will be then made with a 2.0-mm drill bit. A 1.6-mm K-wire will be prepared with distal end bent through 5 and the prepared K-wire will be held by T-handle. The K-wire will be inserted through the entry hole and will be advanced to the medullary canal | Procedure or surgery | group B |
Primary outcome
⦁ Time to bone union
Time frame: 12 weeks
Immediate motion of the MTP joint and partial weightbearing in a stiff-soled shoe will be allowed. full weightbearing will be permitted 4 weeks after the operation. K-wires will be removed when pain subsided, which will be usually at 6 to 8 weeks for metatarsal head or neck fractures. For metatarsal shaft fractures, K-wires will be removed 3 months after the operation. union will be confirmed in radiographs taken at 12 weeks. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.
3 secondary outcomes
⦁ Foot function using the Foot and Ankle Ability Measure (FAAM)
Time frame: 6 months
⦁ Pain intensity using the visual analog scale (VAS)
Time frame: 6 months
⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Closed Antegrade Intramedullary Pinning for Reduction and Fixation of Metatarsal FracturesLink provided by the sponsor.
- Closed Transverse Pinning for Reduction and Fixation of Metatarsal Neck Fractures: Surgical TechniqueLink provided by the sponsor.
- Transverse pinning of concomitant first and second metatarsal fractures using 1.5mm K-wires; case report and technical noteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse Pinning for neck and shaft Metatarsal Fractures and Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures in people with Transverse Pinning for Metatarsal Fractures and Versus Antegrade Intramedullary Pinning for Metatarsal Fractures, 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
⦁ Time to bone union (time frame: 12 weeks). 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 16 Apr 2026.