NCT07558941

Brief Summary

The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.

Trial Health

65
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

April 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 18, 2026

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score

    Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.

    1 year

Secondary Outcomes (8)

  • Elbow flexion range of motion (degrees)

    1 month, 3 months, and 6 months post-intervention

  • Elbow extension range of motion (degrees)

    1 month, 3 months, and 6 months post-intervention

  • Pain assessed using Visual Analog Scale (VAS)

    1 month, 3 months, and 6 months post-intervention

  • Baumann angle (degrees)

    Immediately post-reduction and at 6 months

  • Anterior humeral line alignment (normal/abnormal)

    Immediately post-reduction and at 6 months

  • +3 more secondary outcomes

Study Arms (2)

Conservative treatment

EXPERIMENTAL

Children with Gartland type II supracondylar humeral fractures will be treated conservatively using closed reduction followed by immobilization in an above-elbow cast . Patients will be followed up clinically and radiologically at regular intervals to assess fracture alignment, healing, and functional outcomes.

Other: Conservative treatment by casting

Surgical treatment group

EXPERIMENTAL

Children will undergo surgical treatment via Closed reduction and percutaneous pinning under general anesthesia. Postoperative follow-up will include clinical and radiological assessment of fracture healing, alignment, and complications.

Procedure: surgical treatment via percutaneous pinning UGA

Interventions

surgical treatment vis Closed reduction and percutaneous pinning under general anesthesia. Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications.

Surgical treatment group

Closed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast. Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery.

Conservative treatment

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH

You may not qualify if:

  • Gartland Type I, III, or IV fractures.
  • Open fractures.
  • Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
  • Patients with another injury in the same limb
  • Pathological fractures.
  • Pre-existing elbow pathology or congenital deformity.
  • Inability to comply with follow-up protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

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 doctor at orthopedic department

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 30, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04