NCT03070418

Brief Summary

Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

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

June 1, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

6.6 years

First QC Date

February 18, 2017

Last Update Submit

February 28, 2017

Conditions

Keywords

DHSDCSBoyd and Griffin Classification

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with post surgical trauma

    mini incision

    12 -14 days for soft tissue healing

Secondary Outcomes (1)

  • Proportion of patients with cosmetic scar

    Up to 6 weeks

Study Arms (1)

Abdulhai

EXPERIMENTAL

One show man technique, it is the same of AO Dynamic Hip Screw (DHS) technique using 4 holes plate or smaller, in this case it is enough to make just a 3 cm skin incision.

Procedure: Mini Incision Dynamic Hip Screw Technique

Interventions

This technique is the same of AO Dynamic Hip Screw (DHS) technique using 4 holes plate or smaller, in this case it is enough to make just a 3 cm skin incision over the guide wire that is inserted parallel to the anteversion wire by using the 135° guide fixed on the T-handle; (step 2-2), and continuing AO technique steps, until step 3-4, for the plate assembling we remove the guide wire, and insert the plate sliding it through the skin cut over the femur shaft under the muscles using the plate for dissection the soft tissue above the bone surface non using any tool as periosteal elevator but the plate itself by holding it from its DHS screw canal and in 180 degree rotation position in axial aspect (transvers aspect) using the plate end for soft tissue gentle dissection over the bone, then turning the plate 180 degree over the bone shaft to the right position and sliding the DHS screw plat canal over the DHS screw using the measuring bar. Two skin stitches are enough.

Abdulhai

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presented with intertrochanteric hip fractures

You may not qualify if:

  • not operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sayed Issa's Clinic

Aleppo, Syria

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2017

First Posted

March 3, 2017

Study Start

June 1, 2010

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations