NCT07528092

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Feb 2027

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 7, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

neck and shaft Metatarsal Fractures

Outcome Measures

Primary Outcomes (1)

  • ⦁ 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 Outcomes (3)

  • ⦁ Foot function using the Foot and Ankle Ability Measure (FAAM)

    6 months

  • ⦁ Pain intensity using the visual analog scale (VAS)

    6 months

  • ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications.

    6 months

Study Arms (2)

group A

ACTIVE COMPARATOR

⦁ 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

group B

ACTIVE COMPARATOR

⦁ 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

Interventions

⦁ 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.

group A

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

group B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ⦁ 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

You may not qualify if:

  • ⦁ Fractures combined with Lisfranc injury.
  • Other concomitant fractures.
  • Non displaced fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, 82511, Egypt

RECRUITING

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
orthopedic resident

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations