Mini Incision Dynamic Hip Screw Technique (MIDHST)

February 28, 2017 updated by: Issa, Abdulhamid Sayed, M.D.
Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical trauma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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
  • Tap (when no self-tapping screws are used)
  • Insertion of screw

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presented with intertrochanteric hip fractures

Exclusion Criteria:

  • not operative patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with post surgical trauma
Time Frame: 12 -14 days for soft tissue healing
mini incision
12 -14 days for soft tissue healing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with cosmetic scar
Time Frame: Up to 6 weeks
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Issa, Abdulhamid Sayed, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Abdulhai's Technique

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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