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Superior Gluteal Neuropathy -Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492684
Recruitment Status : Unknown
Verified April 2018 by Mohamed Hamed Mohamed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Hamed Mohamed, Assiut University

Brief Summary:
A prospective study of 50 consecutive patients undergoing total hip arthroplasty, to establish whether there greater incidence of injury to the superior gluteal nerve associated with a particular approach (modified direct lateral approach). The patients will be assessed clinically and electrophysiologically before and after the operation through one year.

Condition or disease Intervention/treatment
ElectroPhys: Mononeuropathy Procedure: total hip arthroplasty

Detailed Description:

Neurological complications following total hip arthroplasty are uncommon, and their impact ranges from transient and trivial to permanent and devastating.

In general, the prevalence rate of neurologic injury after primary hip arthroplasty is estimated as 0.7-3.5% , whereas it may increase up to 7.6% after revision hip arthroplasty.

Direct or indirect injuries of nerves may occur during operative exposure and subsequent procedures. Injuries to the peripheral nerves can come about in several ways: laceration, ischemia, mechanical deformation from compression or distraction, or a combination of these causes.

Peripheral nerve injuries can involve either distant sites or nerves in the immediate vicinity of the hip joint. Sciatic nerve injury is the most common nerve to be injured following total hip arthroplasty. Femoral nerve injury is much less common and is associated with an anterior approach. Its diagnosis is often delayed, but the prognosis is generally better than with sciatic nerve injury.

The direct lateral approach to the hip was described by Hardinge and is based on the observation that the gluteus medius and vastus lateralis are in functional continuity through the thick tendinous periosteum covering the greater trochanter.

This approach involves splitting the gluteus medius and retracting a portion of the muscle anteriorly in continuity with part of the vastus lateralis. It avoids trochanteric osteotomy, but the neurovascular supply of gluteus medius and tensor fascia lata is vulnerable.

The superior gluteal nerve may be compromised during total hip arthroplasty done through the direct lateral approach of Hardinge which puts this nerve at risk when the gluteus medius is split and retracted anteriorly.

The function of the abductors may be impaired after operation if there is damage to the superior gluteal nerve or if the muscle flap is reattached inadequately to the trochanter.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Superior Gluteal Mononeuropathy After Total Hip Arthroplasty Through Modified Direct Lateral Approach
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Intervention Details:
  • Procedure: total hip arthroplasty
    total hip arthroplasty and EMG
    Other Name: electrophysiological study


Primary Outcome Measures :
  1. Number of participants with failure of initial intervention [ Time Frame: one year ]
    prospective case series study study of Superior gluteal mononeuropathy after total hip arthroplasty through modified direct lateral approach by EMG studies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • Age: adults
  • Sex: both males and female
  • Operation: unilateral primary total hip replacement.
Criteria

Inclusion Criteria:

  • Age: adults
  • Sex: both males and female
  • Operation: unilateral primary total hip replacement

Exclusion Criteria:

  • Patient refusal
  • Patients with pre-existing neuromuscular abnormality
  • Preoperative immobility
  • patient with bilateral total hip arthroplasty or hip pathology
  • Revision hip arthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492684


Contacts
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Contact: Mohamed hamed mohamed +0201146962067 dr.mohamedelhamed@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: mohamed hamed mohamed Assiut University
Publications:
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Responsible Party: Mohamed Hamed Mohamed, DR.mohamed hamed, Assiut University
ClinicalTrials.gov Identifier: NCT03492684    
Other Study ID Numbers: neuropathy - hip arthroplasty
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Hamed Mohamed, Assiut University:
nerve injury after total hip arthroplasty
Additional relevant MeSH terms:
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Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases