- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492684
Superior Gluteal Neuropathy -Total Hip Arthroplasty
Study of Superior Gluteal Mononeuropathy After Total Hip Arthroplasty Through Modified Direct Lateral Approach
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Age: adults
- Sex: both males and female
- Operation: unilateral primary total hip replacement.
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohamed hamed mohamed, Assiut University
Publications and helpful links
General Publications
- Edwards BN, Tullos HS, Noble PC. Contributory factors and etiology of sciatic nerve palsy in total hip arthroplasty. Clin Orthop Relat Res. 1987 May;(218):136-41.
- Yang IH. Neurovascular Injury in Hip Arthroplasty. Hip Pelvis. 2014 Jun;26(2):74-8. doi: 10.5371/hp.2014.26.2.74. Epub 2014 Jun 30.
- Solheim LF, Hagen R. Femoral and sciatic neuropathies after total hip arthroplasty. Acta Orthop Scand. 1980 Jun;51(3):531-4. doi: 10.3109/17453678008990836.
- Schmalzried TP, Amstutz HC, Dorey FJ. Nerve palsy associated with total hip replacement. Risk factors and prognosis. J Bone Joint Surg Am. 1991 Aug;73(7):1074-80.
Study record dates
Study Major Dates
Study Start (Anticipated)
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
- neuropathy - hip arthroplasty
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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