ElectroPhys: MononeuropathyNCT03492684
Superior Gluteal Neuropathy -Total Hip Arthroplasty
An observational study of ElectroPhys: Mononeuropathy, run by Assiut University.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ElectroPhys: Mononeuropathy
- What is being tested?
- total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: * Age: adults * Sex: both males and female * Operation: unilateral primary total hip replacement.
Who may be able to join
- Age: adults
- Sex: both males and female
- Operation: unilateral primary total hip replacement
Who cannot join
- Patient refusal
- Patients with pre-existing neuromuscular abnormality
- Preoperative immobility
- patient with bilateral total hip arthroplasty or hip pathology
- Revision hip arthroplasty
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Superior Gluteal Mononeuropathy After Total Hip Arthroplasty Through Modified Direct Lateral Approach
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.
Read the 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.
- Conditions
- ElectroPhys: Mononeuropathy
- Being tested
- total hip arthroplasty
- Keywords
- nerve injury after total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplastyProcedure or surgery
Also called electrophysiological study
total hip arthroplasty and EMG
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ElectroPhys: MononeuropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamed Mohamed, Assiut University
- Investigators
- mohamed hamed mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492684
- Sponsor's protocol ID
- neuropathy - hip arthroplasty
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 3568473Yang 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.
PubMed 27536562Solheim LF, Hagen R. Femoral and sciatic neuropathies after total hip arthroplasty. Acta Orthop Scand. 1980 Jun;51(3):531-4. doi: 10.3109/17453678008990836.
PubMed 6255726Schmalzried 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.
PubMed 1874771
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Superior Gluteal Mononeuropathy After Total Hip Arthroplasty Through Modified Direct Lateral Approach
- ClinicalTrials.gov ID
- NCT03492684
- Acronym / sponsor ID
- neuropathy - hip arthroplasty
- Conditions
- ElectroPhys: Mononeuropathy
- Keywords
- nerve injury after total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Age: adults * Sex: both males and female * Operation: unilateral primary total hip replacement.
Key inclusion criteria (3 listed)
- Age: adults
- Sex: both males and female
- Operation: unilateral primary total hip replacement
Key exclusion criteria (5 listed)
- Patient refusal
- Patients with pre-existing neuromuscular abnormality
- Preoperative immobility
- patient with bilateral total hip arthroplasty or hip pathology
- Revision hip arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip arthroplastyAlso: electrophysiological studytotal hip arthroplasty and EMG | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Background: PubMed 3568473Edwards 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.
- Background: PubMed 27536562Yang 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.
- Background: PubMed 6255726Solheim LF, Hagen R. Femoral and sciatic neuropathies after total hip arthroplasty. Acta Orthop Scand. 1980 Jun;51(3):531-4. doi: 10.3109/17453678008990836.
- Background: PubMed 1874771Schmalzried 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed hamed mohamed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of ElectroPhys: Mononeuropathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed hamed mohamed (+0201146962067, dr.mohamedelhamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with failure of initial intervention (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492684, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.