Intratrochontric FractureMIDHSTNCT03070418
Mini Incision Dynamic Hip Screw Technique
A study testing Mini Incision Dynamic Hip Screw Technique in people with Intratrochontric Fracture, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
Trial summary
Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical trauma. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intratrochontric Fracture
- What is being tested?
- Mini Incision Dynamic Hip Screw Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSyria
- Study dates
- Jun 2010to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presented with intertrochanteric hip fractures
Who cannot join
- not operative patients
Trial locations and contacts
1 site in 1 country.
About this study
Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical trauma.
Read the 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
- 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.
- 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
- 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.
- Set the triple reamer to 10 mm shorter than the measured length. The hole is drilled over the guide wire.
- Tapping is only required in young patients with dense bone.
- 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
- Tap (when no self-tapping screws are used)
- Insertion of screw
- Conditions
- Intratrochontric Fracture
- Being tested
- Mini Incision Dynamic Hip Screw Technique
- Keywords
- DHS, DCS, Boyd and Griffin Classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Incision Dynamic Hip Screw TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Mini Incision Dynamic Hip Screw Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with post surgical trauma
mini incision
Measured: 12 -14 days for soft tissue healing
Secondary outcomes (1)
Proportion of patients with cosmetic scar
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startJun 2010
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intratrochontric FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070418
- Sponsor's protocol ID
- Abdulhai's Technique
- Acronym
- MIDHST
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Incision Dynamic Hip Screw Technique
- ClinicalTrials.gov ID
- NCT03070418
- Acronym / sponsor ID
- MIDHST / Abdulhai's Technique
- Conditions
- Intratrochontric Fracture
- Keywords
- DHS, DCS, Boyd and Griffin Classification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Study start
- Jun 2010
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- 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.
- Set the triple reamer to 10 mm shorter than the measured length. The hole is drilled over the guide wire.
- Tapping is only required in young patients with dense bone.
- 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
- Tap (when no self-tapping screws are used)
- Insertion of screw
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdulhai | Experimental | Procedure: Mini Incision Dynamic Hip Screw TechniqueOne 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presented with intertrochanteric hip fractures
Key exclusion criteria (1 listed)
- not operative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini Incision Dynamic Hip Screw TechniqueThis 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. | Procedure or surgery | Abdulhai |
Primary outcome
Proportion of patients with post surgical trauma
Time frame: 12 -14 days for soft tissue healing
mini incision
1 secondary outcome
Proportion of patients with cosmetic scar
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Incision Dynamic Hip Screw Technique in people with Intratrochontric Fracture, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with post surgical trauma (time frame: 12 -14 days for soft tissue healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.