Cross Therapy Registry - Edema - US

NCT04700735 | Completed FDA Device

• 1 other identifier: FSK-REG-001-US
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 3

Brief Summary

The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

Conditions

Edema Leg

Outcome Measures

Primary Outcomes (2)

• Safety

  Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC).

  One year

• Performance

  Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.

  One year

Secondary Outcomes (2)

• Summary of routinely collected performance data

  One Year

• Summary of Health Economic Impact

  One year

Interventions

geko Neuromuscular Electro Stimulator (NMES) DEVICE

Neuromuscular Electro Stimulator (NMES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have been identified to receive gekoTM therapy as part of their standard care for edema reduction.

You may qualify if:

• Male or female aged ≥ 18 years and able to provide written informed consent.
• Intact healthy skin at the site of gekoTM device application.
• Subjects receiving gekoTM therapy as part of their standard care for edema reduction.

You may not qualify if:

• Pregnancy or breast feeding.
• Use of any concurrent neuro-modulation device.
• Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
• No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
• Bilateral lower limb surgical intervention.
• Unicondylar knee replacement surgical intervention.

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (3)

Luminis Health Research Institute

Annapolis, Maryland, 21401, United States

Location

Genesee Orthopedics

New Hartford, New York, 13413, United States

Location

JIS Orthopedics

New Albany, Ohio, 43054, United States

Location

Related Publications (17)

• Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring;19(1):e31-7. doi: 10.1055/s-0031-1278361.

  PMID: 22477572 BACKGROUND

• Jawad H, Bain DS, Dawson H, Crawford K, Johnston A, Tucker A. The effectiveness of a novel neuromuscular electrostimulation method versus intermittent pneumatic compression in enhancing lower limb blood flow. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):160-5. doi: 10.1016/j.jvsv.2013.10.052. Epub 2014 Jan 28.

  PMID: 26993181 BACKGROUND

• Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.

  PMID: 23999610 BACKGROUND

• Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.

  PMID: 24722790 BACKGROUND

• Zhang Q, Styf J, Ekstrom L, Holm AK. Effects of electrical nerve stimulation on force generation, oxygenation and blood volume in muscles of the immobilized human leg. Scand J Clin Lab Invest. 2014 Aug;74(5):369-77. doi: 10.3109/00365513.2014.898323. Epub 2014 Apr 3.

  PMID: 24697619 BACKGROUND

• Yilmaz S, Calbiyik M, Yilmaz BK, Aksoy E. Potential role of electrostimulation in augmentation of venous blood flow after total knee replacement: A pilot study. Phlebology. 2016 May;31(4):251-6. doi: 10.1177/0268355515580473. Epub 2015 Apr 6.

  PMID: 25852131 BACKGROUND

• Griffin M, Bond D, Nicolaides A. Measurement of blood flow in the deep veins of the lower limb using the geko neuromuscular electro-stimulation device. Int Angiol. 2016 Aug;35(4):406-10. Epub 2016 Mar 2.

  PMID: 26934561 BACKGROUND

• Barnes R, Madden LA, Chetter IC. Fibrinolytic effects of peroneal nerve stimulation in patients with lower limb vascular disease. Blood Coagul Fibrinolysis. 2016 Apr;27(3):275-80. doi: 10.1097/MBC.0000000000000409.

  PMID: 26397885 BACKGROUND

• Wainwright TW, Burgess LC, Middleton RG. A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery. Heliyon. 2018 Jul 18;4(7):e00697. doi: 10.1016/j.heliyon.2018.e00697. eCollection 2018 Jul.

  PMID: 30094367 BACKGROUND

• Mahmood, Ihsan FRCS (T&O); Chandler, Henry MRCS; Kottam, Lucksy PhD; Eardley, William FRCS (T&O); Rangan, Amar FRCS (T&O); Baker, Paul FRCS (T&O) Neuromuscular Electrostimulation Device Reduces Preoperative Edema and Accelerates Readiness for Theater in Patients Requiring Open Reduction Internal Fixation for Acute Ankle Fracture, Techniques in Foot & Ankle Surgery: December 2020 - Volume 19 - Issue 4 - p 215-219 doi: 10.1097/BTF.0000000000000257

  BACKGROUND

• Jones NJ, Ivins N, Ebdon V, Hagelstein S, Harding KG. Neuromuscular electrostimulation on lower limb wounds. Br J Nurs. 2018 Nov 8;27(20):S16-S21. doi: 10.12968/bjon.2018.27.Sup20.S16.

  PMID: 30418851 BACKGROUND

• Harris C, Duong R, Vanderheyden G, Byrnes B, Cattryse R, Orr A, Keast D. Evaluation of a muscle pump-activating device for non-healing venous leg ulcers. Int Wound J. 2017 Dec;14(6):1189-1198. doi: 10.1111/iwj.12784. Epub 2017 Aug 2.

  PMID: 28770561 BACKGROUND

• Harris C, Ramage D, Boloorchi A, Vaughan L, Kuilder G, Rakas S. Using a muscle pump activator device to stimulate healing for non-healing lower leg wounds in long-term care residents. Int Wound J. 2019 Feb;16(1):266-274. doi: 10.1111/iwj.13027. Epub 2018 Nov 20.

  PMID: 30460740 BACKGROUND

• Pichonnaz C, Bassin JP, Lecureux E, Currat D, Jolles BM. Bioimpedance spectroscopy for swelling evaluation following total knee arthroplasty: a validation study. BMC Musculoskelet Disord. 2015 Apr 25;16:100. doi: 10.1186/s12891-015-0559-5.

  PMID: 25907994 BACKGROUND

• Loyd BJ, Kittelson AJ, Forster J, Stackhouse S, Stevens-Lapsley J. Development of a reference chart to monitor postoperative swelling following total knee arthroplasty. Disabil Rehabil. 2020 Jun;42(12):1767-1774. doi: 10.1080/09638288.2018.1534005. Epub 2019 Jan 22.

  PMID: 30668214 BACKGROUND

• Loyd BJ, Stackhouse S, Dayton M, Hogan C, Bade M, Stevens-Lapsley J. The relationship between lower extremity swelling, quadriceps strength, and functional performance following total knee arthroplasty. Knee. 2019 Mar;26(2):382-391. doi: 10.1016/j.knee.2019.01.012. Epub 2019 Feb 14.

  PMID: 30772186 BACKGROUND

• Virchow, R. (1856).

  BACKGROUND

Study Officials

• Keith Berend, MD

  JIS Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: June 22, 2021
• Primary Completion: August 31, 2023
• Study Completion: November 9, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)