NCT03492684

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 23, 2018

Last Update Submit

April 8, 2018

Conditions

Keywords

nerve injury after total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

total hip arthroplasty and EMG

Also known as: electrophysiological study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 3568473BACKGROUND
  • 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.

    PMID: 27536562BACKGROUND
  • 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.

    PMID: 6255726BACKGROUND
  • 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.

    PMID: 1874771BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • mohamed hamed mohamed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed hamed mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.mohamed hamed

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 10, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 10, 2018

Record last verified: 2018-04