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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03492684
Other study ID # neuropathy - hip arthroplasty
Secondary ID
Status Not yet recruiting
Phase
First received March 23, 2018
Last updated April 8, 2018
Start date September 1, 2018
Est. completion date September 1, 2019

Study information

Verified date April 2018
Source Assiut University
Contact Mohamed hamed mohamed
Phone +0201146962067
Email dr.mohamedelhamed@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
total hip arthroplasty
total hip arthroplasty and EMG

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

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. — View Citation

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. — View Citation

Solheim LF, Hagen R. Femoral and sciatic neuropathies after total hip arthroplasty. Acta Orthop Scand. 1980 Jun;51(3):531-4. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with failure of initial intervention prospective case series study study of Superior gluteal mononeuropathy after total hip arthroplasty through modified direct lateral approach by EMG studies one year