Hip Abductor Muscle Dysfunction After Nailing of Proximal Femoral Fractures, Incidence and Contributing Factors.

March 16, 2020 updated by: Ahmed Adel Khalifa, South Valley University
Proximal femoral fractures(PFFs) are common with advancing age. Proximal femoral nail (PFN) is now increasingly used to fix unstable fractures. Studies have demonstrated that muscle strength deficit is significantly large after PFFs. N. Ivanova et al found that hip muscle isometric strength for the fractured leg was significantly decreased 1 week and 6 months postoperatively. Besides, a recent study done by Nitin Wale et al concluded that abductor weakness and trendeleburg gait are fairly common in patients treated with PFN and this complaint is often overlooked. Despite significant improvement in muscle function after at least 6 months of physiotherapy as demonstrated by previous studies, we didn't come over a study explaining the main causes of remaining abductor lurch in patients with united fracture of the proximal femur treated using proximal femoral nail (short type).

Study Overview

Status

Unknown

Conditions

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:

    1. Harris hip score.
    2. Leg length discrepancy: measured as the true length from the ASIS to the medial malleolus.
    3. The bulk of the abductor musculature: measured as the distance between the ASIS anteriorly and the ischial tuberosity posteriorly.
    4. 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:

    1. 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.
    2. Neck shaft angle: as the angle between the neck axis and the anatomical axis of the proximal femur.
    3. Leg length discrepancy: as the distance between a fixed reference point on the lesser trochanter on both sides and the trans-ischial line.
    4. Amount of nail prominent from the greater trochanter.
    5. 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

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Qina
      • Qinā, Qina, Egypt, 83523
        • Recruiting
        • Qena university hospital, South Valley University
        • Contact:
          • Ahmed A Khalifa
          • Phone Number: 00201224466151

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients (male or females) treated in our hospital for fracture of the proximal femur with or without obvious abductor lurch

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

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

  • 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

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

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 (Actual)

January 18, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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