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ClinicalTrials.gov PRS DRAFT Receipt (Working Version)
Last Update: 02/28/2017 14:05
ClinicalTrials.gov ID: NCT03070418
Study Identification
Unique Protocol ID: Abdulhai's Technique
Brief Title: Mini Incision Dynamic Hip Screw Technique ( MIDHST )
Official Title: Mini Incision Dynamic Hip Screw Technique
Secondary IDs:
Study Status
Record Verification: February 2017
Overall Status: Completed
Study Start: June 2010 []
Primary Completion: January 2017 [Actual]
Study Completion: January 2017 [Actual]
Sponsor/Collaborators
Sponsor: Issa, Abdulhamid Sayed, M.D.
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
U.S. FDA IND/IDE: No
Human Subjects Review: Board Status: Approved
Approval Number: 2/25/2013
Board Name: Medical Syrian Board
Board Affiliation: Syrian Ministry of health
Phone: 00963113339600
Email: info@moh.gov.sy
Address:
Data Monitoring: Yes
FDA Regulated Intervention: No
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Study Description
Brief Summary: Femoral cervical fractures fixation with DHS plate throw 3 cm incision and
minimum surgical trauma.
Detailed Description: 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.
Technique
Step 1─reduction
In many cases the traction table is used. The reduction is done on this table and
before the patient is draped. Important also is to guarantee smooth access of
the image intensifier in both planes; AP and lateral.
Step 2─guide wire insertion
1. The anteversion of the femoral neck is determined with a long K-wire
inserted with the blunt end first. An alternative is to use a long, non-
threaded K-wire.
2. Under X-ray control, the guide wire is inserted parallel to the anteversion
wire by using the 135° guide fixed on the T-handle.
Step 3─screw insertion
1. The length of the screw must be measured/determined with the guide
wire. Note that the screw must be 10 mm shorter than the length of the
guide wire. The surgeon will deduct 10 mm of the measured length to
determine the screw length.
2. Set the triple reamer to 10 mm shorter than the measured length. The
hole is drilled over the guide wire.
3. Tapping is only required in young patients with dense bone.
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.
• The plate is slid over the wrench.
• The DHS screw is attached to the coupling wrench.
• The sleeve is assembled over the wrench.
Step 4─plate fixation
Impact the plate in order to have best contact with the femur. The plate is fixed
with conventional 4.5 mm screws:
• Drill bit 3.2 mm with sleeve
• Measuring
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• Tap (when no self-tapping screws are used)
• Insertion of screw
Conditions
Conditions: Intratrochontric Fracture
Keywords: DHS
DCS
Boyd and Griffin Classification
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: N/A
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 65 [Actual]
Arms and Interventions
Arms Assigned Interventions
Experimental: Abdulhai
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/Surgery: Mini Incision Dynamic Hip Screw
Technique
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.
Outcome Measures
Primary Outcome Measure:
1. Proportion of patients with post surgical trauma
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mini incision
[Time Frame: 12 -14 days for soft tissue healing]
Secondary Outcome Measure:
2. Proportion of patients with cosmetic scar
[Time Frame: Up to 6 weeks]
NOTE : Outcome Measure Description has not been entered.
Eligibility
Minimum Age: 21 Years
Maximum Age: 75 Years
Sex: All
Gender Based: No
Accepts Healthy Volunteers: Yes
Criteria: Inclusion Criteria:
• Patients presented with intertrochanteric hip fractures
Exclusion Criteria:
• not operative patients
Contacts/Locations
Central Contact Person:
Central Contact Backup:
Study Officials: NOTE : Study Official is required by the WHO and ICMJE.
Locations: Syria
Dr. Sayed Issa's Clinic
Aleppo, Syria
Contact: Abdulhamid Sayed Issa, Dr. 00963944838097
orthoasi@yahoo.com
Contact: Amjad Abdulhai 00963944297030
IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
NOTE : IPD Sharing Plan Description has not been entered.
NOTE : IPD Sharing Time Frame has not been entered.
NOTE : IPD Sharing Access Criteria has not been entered.
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References
Citations:
Links:
Available IPD/Information:
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
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