Transverse Pinning Versus Antegrade Intramedullary Pinning for Neck and Shaft Metatarsal Fractures

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

Study Overview

• Status: Recruiting
• Conditions: Transverse Pinning for Metatarsal Fractures; Versus Antegrade Intramedullary Pinning for Metatarsal Fractures
• Intervention / Treatment: Procedure: Transverse Pinning for neck and shaft Metatarsal Fractures; Procedure: 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University Hospital
    • Contact: alaa Abdelrahman Abdelrasheed; Phone Number: +201016878101; Email: alaa_abdelrahman_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ⦁ 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

Exclusion Criteria:

• ⦁ Fractures combined with Lisfranc injury.

  • Other concomitant fractures.
  • Non displaced fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; ⦁ Group A: 20 patients who will be treated by transverse pinning for neck or shaft metatarsal fractures	Procedure: 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.
Active Comparator: group B; ⦁ Group B: 20 patients who will be treated by antegrade intramedullary pinning for neck or shaft metatarsal fractures.	Procedure: Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
⦁ 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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
⦁ Foot function using the Foot and Ankle Ability Measure (FAAM)	Foot function will be evaluated by the Foot and Ankle Ability Measure (FAAM	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").	6 months
⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications.		6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

Helpful Links

• Closed Antegrade Intramedullary Pinning for Reduction and Fixation of Metatarsal Fractures
• Closed Transverse Pinning for Reduction and Fixation of Metatarsal Neck Fractures: Surgical Technique
• Transverse pinning of concomitant first and second metatarsal fractures using 1.5mm K-wires; case report and technical note

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neck and shaft Metatarsal Fractures
• Other Study ID Numbers: soh-med-26-1-5MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No