NCT06659107

Brief Summary

This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 6, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

October 23, 2024

Last Update Submit

October 24, 2024

Conditions

Proximal Humeral Fractures

Keywords

Proximal humeral fracturesMutual linking

Outcome Measures

Primary Outcomes (2)

  • Functional outcome

    Shoulder functional status using the American shoulder and elbow surgeons score (ASES) range from 0 to100, 0 being the worst and 100 being the best

    One year

  • Radiological outcome

    The percentage of patients achieving union of the fracture assesed by plain X-ray shoulder anteroposterior and lateral views.

    8 weeks

Study Arms (1)

Elderly patients with proximal humeral fractures Neer type 2 and 3

EXPERIMENTAL

Both sexes, age from 60 to 80

Procedure: Closed reduction and fixation by K- wires

Interventions

Closed reduction and fixation by K- wiresPROCEDURE

Fixation by k-wires with mutual linking technique

Elderly patients with proximal humeral fractures Neer type 2 and 3

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both sexes
  • Age from 60 to80 years
  • or 3 parts fracture
  • recent injury less than 3 weeks

You may not qualify if:

  • parts fracture
  • old injury more than 3 weeks
  • previous surgeries or pathologies affecting shoulder range of motion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university hospitals

Cairo, 6023, Egypt

Location

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of orthopedic surgery

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 26, 2024

Study Start

September 6, 2023

Primary Completion

July 12, 2024

Study Completion

September 6, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)