- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311892
Hip Abductor Muscle Dysfunction After Nailing of Proximal Femoral Fractures, Incidence and Contributing Factors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a group of patients treated at our hospital for fracture of the proximal femur using different generations of the proximal femoral nail and after full fracture union, although they had an excellent hip function we noticed that the majority of the patients still suffering from limping and abductor lurch with a Trendelenburg gait.
Purpose: to detect hip abductor muscle dysfunction after treating proximal femoral fracture using a proximal femoral nail (short type)
Research Questions: what is the reason(s) for remaining abductor lurch in patients with proximal femoral fracture treated with PFN?
Study Design: an observational retrospective
Study Group number: 20 patients (to be modified according to the number of patients registered at the study setting)
Assessment: (will be measured on both operated and non-operated sides)
Clinical:
- Harris hip score.
- Leg length discrepancy: measured as the true length from the ASIS to the medial malleolus.
- The bulk of the abductor musculature: measured as the distance between the ASIS anteriorly and the ischial tuberosity posteriorly.
- Trendelenburg gait: assessed using modified McKay criteria2. These criteria measure pain symptoms, gait pattern, Trendelenburg sign status, and the range of hip joint movement
Radiological:
- Fracture union: assessed using Apley and Solomon's criteria6. Complete bone union according to these criteria is defined as the time at which there is no pain upon local palpation, no swelling in the limb, ability to walk without support and pain-free, and evidence of a radiographic bridging callus or trabecula between fragments.
- Neck shaft angle: as the angle between the neck axis and the anatomical axis of the proximal femur.
- Leg length discrepancy: as the distance between a fixed reference point on the lesser trochanter on both sides and the trans-ischial line.
- Amount of nail prominent from the greater trochanter.
- Hip horizontal offset: the length of a line drawn from the centre of the femoral head and perpendicular to the anatomical axis of the femur.
- Neurophysiological:
EMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The EMGs will be performed by the same neurophysiologist. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root. First, resting activities will be assessed for the signs of acute denervation (fibrillation and positive sharp waves), followed by observation of the recruitment pattern examination of the motor unit action potential (MUAP) amplitudes, and time characteristics. Finally, motor patterns of interferences will be investigated during muscle contractions to obtain information about denervation and reinnervation of examined muscles
Outcomes to be measured:
- Primary outcome: Neurophysiological status of Hip abductors function (EMG)
- Secondary outcome: HHS, altered radiological hip biomechanics
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ahmed A Khalifa, MD, FRCS
- Phone Number: 00201224466151
- Email: ahmed_adel0391@med.svu.edu.eg
Study Contact Backup
- Name: Mohamed Khaled, MSc
- Phone Number: 00201066866653
- Email: mohammedkhaled015@gmail.com
Study Locations
-
-
Qina
-
Qinā, Qina, Egypt, 83523
- Recruiting
- Qena university hospital, South Valley University
-
Contact:
- Ahmed A Khalifa
- Phone Number: 00201224466151
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients treated with this type of implant for proximal femoral fracture with or without abductor lurch, follow up more than 6 months, fracture full union
Exclusion Criteria:
- patients suffering from neurological disorder affecting the same side of surgery (polio- hemiplegia), less than 6 months follow up, fracture non- or delayed union, polytraumatized patients, pathological fractures
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip abductor muscles neuro-physiological state
Time Frame: 4 months
|
the state of the hip abductor muscles regarding it innervation and the state of the muscle fibers itself
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proximal femoral shortening
Time Frame: 4 months
|
shortening of the treated side measured on the AP radiograph
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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