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Recruiting NCT07528092

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

No phase Interventional Transverse Pinning for Metatarsal Fractures Versus Antegrade Intramedullary Pinning for Metatarsal Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transverse Pinning for neck and shaft Metatarsal Fractures, Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures.
Who it may be relevant to
Registry conditions: Transverse Pinning for Metatarsal Fractures, Versus Antegrade Intramedullary Pinning for Metatarsal Fractures. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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 prep

Primary outcome measures

  • ⦁ Time to bone union [Time frame: 12 weeks]
Secondary outcome measures (3)
  • ⦁ 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sohag University Hospital — Sohag

Identifiers

NCT: NCT07528092 · soh-med-26-1-5MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗