NCT01785251

Brief Summary

Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein Thrombosis (DVT) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. The use of calf muscle neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established. The main objectives are:

  1. 1.To establish if patients in the early post-operative period have tolerance for NMES.
  2. 2.To determine if applying NMES to patients immediately post-THA increases venous outflow from the lower limb over resting conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

February 1, 2013

Last Update Submit

February 4, 2013

Conditions

Deep Vein ThrombosisTotal Hip Arthroplasty

Keywords

Neuromuscular electrical stimulationNMESDeep vein thrombosisDVTtotal hip arthroplastylower limb hemodynamics

Outcome Measures

Primary Outcomes (1)

  • Lower limb haemodynamic performance

    Duplex Doppler ultrasound will be used as the outcome measure. Both legs will be measured for hemodynamic performance in the popliteal vein by placing the probe at the popliteal fossa. Measurements of peak venous velocity (cm/s), popliteal vein diameter (cm), time averaged mean velocity (TAMEAN, cm/s) and volume flow (ml/min) will be recorded. Doppler measurements will be taken initially at rest, before the application of NMES and once again when the NMES session had commenced.

    4 hours

Secondary Outcomes (1)

  • Patient comfort during application of NMES

    4 hours

Study Arms (1)

NMES

EXPERIMENTAL

Application of neuromuscular electrical stimulation to the calf muscles of the patient in order to elicit contraction of the calf muscle pump and thus, eject venous blood proximally.

Device: Neuromuscular Electrical Stimulation

Interventions

Neuromuscular Electrical StimulationDEVICE

Applied using a custom built, medically approved stimulator called the Duo-STIM. NMES to be applied to the calf muscles to elicit a muscular contraction to eject blood through the venous system.

NMES

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent total hip arthroplasty the previous day

You may not qualify if:

  • Patients with Diabetes Mellitus
  • Patients with Peripheral Vascular Disease
  • Patients currently involved in another trial
  • Previous diagnosis of DVT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid-Western Regional Orthoapedic Hospital Croom

Limerick, Ireland

Location

Related Publications (1)

  • Broderick BJ, Breathnach O, Condon F, Masterson E, Olaighin G. Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty. J Orthop Surg Res. 2013 Mar 5;8:3. doi: 10.1186/1749-799X-8-3.

    PMID: 23497524DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Gearóid ÓLaighin, BEng, MEng, PhD

    National University of Ireland, Galway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

IE(1)