NCT07705347

Brief Summary

evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

June 29, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 29, 2026

Last Update Submit

July 10, 2026

Conditions

Forearm Fractures

Keywords

Diaphyseal forearm fractures in adolescents

Outcome Measures

Primary Outcomes (1)

  • Functional outcome assessed using the Grace and Eversmann scoring system.

    6 months

Secondary Outcomes (1)

  • Radiographic Bone Union Time

    6 months

Study Arms (2)

Group (plate)

ACTIVE COMPARATOR

Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system

Procedure: Open reduction and internal fixation

Group (TENs)

ACTIVE COMPARATOR

Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs)

Procedure: Closed or mini-open reduction and fixation

Interventions

Open reduction and internal fixationPROCEDURE

Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system.

Group (plate)
Closed or mini-open reduction and fixationPROCEDURE

Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs).

Group (TENs)

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 10 to 16 years (at time of injury).
  • Fracture pattern: diaphyseal fracture involving both the radius or ulna.
  • o Fracture location: Diaphysis defined as the segment between the proximal metaphyseal flare (distal to bicipital tuberosity for radius; distal to coronoid process for ulna) and the distal metaphyseal flare (within 3 cm of the distal physis).
  • Indication for surgery: Failure of closed reduction or unacceptable alignment after attempted closed reduction, defined as:
  • Angulation \> 15° in any plane (sagittal or frontal).
  • Translation \> 50% of bone diameter.
  • Bayonet apposition.
  • Open fracture (Gustilo type I).
  • Inability to maintain acceptable reduction after cast immobilization (loss of reduction).
  • Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).

You may not qualify if:

  • Open fracture Gustilo type II \& III.
  • Pathological fracture (secondary to bone cyst, tumor, osteogenesis imperfecta, etc.).
  • Neurovascular compromise requiring emergent exploration (e.g., acute compartment syndrome, pulseless limb after reduction).
  • Floating elbow (ipsilateral supracondylar humerus fracture + forearm fracture).
  • Monteggia or Galeazzi fracture-dislocation patterns
  • Metabolic bone disease (e.g., rickets, osteomalacia, renal osteodystrophy).
  • Neuromuscular disorder affecting upper extremity function (e.g., cerebral palsy, muscular dystrophy, brachial plexus injury).
  • Active infection at surgical site or systemic infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Sohag university

Sohag, Egypt

Location

MeSH Terms

Interventions

Open Fracture ReductionFracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • ramadan moanes

    Faculty of medicine, Sohag university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramadan Moanes

CONTACT

+201068323176ramadanmoanes@gmail.com

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
Resident

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 15, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

EG(1)