Total Hip ReplacementNCT02425917

IPC-CALF Versus GEKO in Post-op Total Hip Patients

A study testing geko and IPC-Calf in people with Total Hip Replacement, run by Firstkind Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Total Hip Replacement
What is being tested?: geko and IPC-Calf
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2017to Jan 2018
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female
Aged over 18-80 years
Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
No history or signs of drug abuse (including alcohol), licit or illicit.
Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator (PI) during the thirty (30) days preceding the study.
Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
Able and willing to follow the protocol requirements.

Who cannot join

Are requiring hip revision surgery
History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
Significant Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
Recent trauma to lower limb.
Chronic Obesity (BMI Index >40kg/m2).

Show all 12Show fewer

Pregnancy.
Significant history of following diseases i. Cardiovascular: Recent MI (< 6 months) ii. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare metal stent (BMS) and < 12 months for Drug Eluding Stent (DES) iii. Moderate to severe CCF, uncontrolled AF iv. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies v. Renal: Moderate to severely impaired renal function vi. Hepatic: Moderate to severely impaired hepatic function vii. Psychiatric disorders viii. Dermatological conditions affecting lower limbs ix. Haematological conditions i.e. coagulation disorders, sickle cell disease
A pulse rate of less than 40 beats/minute
A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
Any significant illness during the four (4) weeks preceding the hip replacement surgery.
Participation in any clinical study during the eight (8) weeks preceding the screening period

About this study

Official title: Comparison of Intermittent Pneumatic Compression (IPC) of the Calf and gekoTM Neuromuscular Electrostimulation (NMES) Device on Lower Limb Circulation Following Elective Total Hip Replacement (THR)

This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.

Conditions: Total Hip Replacement
Being tested: geko, IPC-Calf

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gekoDevice
neuromuscular electrostimulator
IPC-CalfDevice
IPC used on calf with or without geko

Study groups in NCT02425917
Study group	Role	What they receive
geko	Experimental	Not described Receives: Device: geko
ipc-calf	Active comparator	intermittent pneumatic compression of the calf Receives: Device: IPC-Calf

What is being measured

The primary outcome is the main question the study is designed to answer.

Ultra sound measurements of haemodynamics
Measured: 10mins

Secondary outcomes (2)

Adverse event rate
Measured: 3 hrs
patient rated tolerability
A questionnaire has been designed to record the opinion of the patient with regard to both devices, in particular how comfortable the devices were to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable
Measured: 3 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2017Jan 2018

First posted24 Apr 2015 (estimated)
Study startJun 2017 (estimated)
Primary completionDec 2017 (estimated)
Study completionJan 2018 (estimated)

Why it stopped: not relevant to the sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425917
Sponsor's protocol ID: FKD-IPC-002
Status last verified: May 2017
First submitted: 14 Apr 2015
Last updated: 21 Jul 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

All Total Hip Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Intermittent Pneumatic Compression (IPC) of the Calf and gekoTM Neuromuscular Electrostimulation (NMES) Device on Lower Limb Circulation Following Elective Total Hip Replacement (THR)
ClinicalTrials.gov ID: NCT02425917
Acronym / sponsor ID: FKD-IPC-002
Conditions: Total Hip Replacement
Study type: Interventional
Recruitment status: WithdrawnReason stopped: not relevant to the sponsor
Enrolment: 0 participants (actual)
Lead sponsor: Firstkind LtdIndustry (pharma, biotech, devices)
Study start: Jun 2017 (estimated)
Primary completion: Dec 2017 (estimated)
Study completion: Jan 2018 (estimated)
First posted: 24 Apr 2015 (estimated)
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.

This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
geko	Experimental	Device: geko
ipc-calf	Active comparator	Device: IPC-Calfintermittent pneumatic compression of the calf

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and Female
Aged over 18-80 years
Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
No history or signs of drug abuse (including alcohol), licit or illicit.

Key exclusion criteria (12 listed)

Are requiring hip revision surgery
History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
Significant Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
Recent trauma to lower limb.

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
gekoneuromuscular electrostimulator	Device	geko
IPC-CalfIPC used on calf with or without geko	Device	ipc-calf

Primary outcome

Ultra sound measurements of haemodynamics
Time frame: 10mins

2 secondary outcomes

Adverse event rate
Time frame: 3 hrs
patient rated tolerability
Time frame: 3 hrs

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.

Related trials for Total Hip Replacement

Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing geko and IPC-Calf in people with Total Hip Replacement, run by Firstkind Ltd.

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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultra sound measurements of haemodynamics (time frame: 10mins). 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 NCT02425917.

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 21 Jul 2017.