Swelling Management After Total Knee Arthroplasty

NCT04841356 | Completed

• 1 other identifier: 1722208-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to estimate the initial efficacy and feasibility of an inelastic compression garment donned immediately after TKA on peak swelling in 14 subjects.

Conditions

Total Knee Arthroplasty

Keywords

swelling; compression

Outcome Measures

Primary Outcomes (1)

• Change in total limb swelling from baseline to day 4 and weeks 1, 2, 3, and 6 postoperative

  Assesses swelling in the lower extremity using single frequency bioelectrical impedance.

  preoperatively, day 4 and weeks 1, 2, 3, and 6 postoperatively

Secondary Outcomes (2)

• Adherence to the intervention as measured by self-report logs

  week 3 postoperatively

• Subject satisfaction as measured by a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied"

  week 3 postoperatively

Study Arms (1)

ICG

EXPERIMENTAL

Immediate Compression Garment

Procedure: Immediate Compression Garment

Interventions

Immediate Compression Garment PROCEDURE

Immediately following surgery, in the operating room, the compression garment will be donned on the surgical limb. The garment is set to the following pressures to facilitate gradient compression: 40mm Hg (lower leg), 30mm Hg (knee), 20 mm Hg (thigh) utilizing a standardized garment tensioning tool. Subjects will wear the garment during all waking hours (target wear time of 12 hours daily) for the first 3 weeks after surgery. Additionally, subjects will be instructed to perform a therapeutic exercise program designed to manage swelling by targeting major lower extremity musculature (gastrocnemius, soleus, quadriceps, hamstrings, and gluteal musculature) and promoting venous and lymphatic return. These exercises will be performed five times daily during the first three weeks after surgery. Subjects will receive standard of care rehabilitation following surgery as directed and coordinated by the surgeon and participant. This rehabilitation is not part of this research study.

Also known as: compression

ICG

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo a primary, unilateral total knee arthroplasty secondary to end-stage osteoarthritis

You may not qualify if:

• Discharge to location other than home after surgery
• History of heart failure, lymphatic insufficiency, hepatic disease, pre-existing pitting edema, varicose vein ligation or any other condition associated with lower extremity swelling
• Unstable orthopedic conditions (besides OA/TKA) that limit function
• Other neurological, vascular, or cardiac problems that limit function or cause chronic lower extremity swelling
• No caregiver or inability to touch toes which can affect the ability to don/doff the compression garment
• Current smoker or history of substance abuse
• Surgical complication necessitating an altered course of rehabilitation
• Uncontrolled diabetes (hemoglobin A1c level \>8.0)
• Body mass index \>40 kg/m2

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Joint Replacement: collaborator
• medi: collaborator

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Related Publications (21)

• Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.

  PMID: 30988126 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

• Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

  PMID: 20710093 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

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• Moreland JD, Richardson JA, Goldsmith CH, Clase CM. Muscle weakness and falls in older adults: a systematic review and meta-analysis. J Am Geriatr Soc. 2004 Jul;52(7):1121-9. doi: 10.1111/j.1532-5415.2004.52310.x.

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• Brown M, Sinacore DR, Host HH. The relationship of strength to function in the older adult. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:55-9. doi: 10.1093/gerona/50a.special_issue.55.

  PMID: 7493219 BACKGROUND

• Connelly DM, Vandervoort AA. Effects of detraining on knee extensor strength and functional mobility in a group of elderly women. J Orthop Sports Phys Ther. 1997 Dec;26(6):340-6. doi: 10.2519/jospt.1997.26.6.340.

  PMID: 9402571 BACKGROUND

• Moxley Scarborough D, Krebs DE, Harris BA. Quadriceps muscle strength and dynamic stability in elderly persons. Gait Posture. 1999 Sep;10(1):10-20. doi: 10.1016/s0966-6362(99)00018-1.

  PMID: 10469937 BACKGROUND

• LaStayo PC, Meier W, Marcus RL, Mizner R, Dibble L, Peters C. Reversing muscle and mobility deficits 1 to 4 years after TKA: a pilot study. Clin Orthop Relat Res. 2009 Jun;467(6):1493-500. doi: 10.1007/s11999-009-0801-2. Epub 2009 Mar 31.

  PMID: 19333672 BACKGROUND

• Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14.

  PMID: 18448878 BACKGROUND

• Mizner RL, Stevens JE, Snyder-Mackler L. Voluntary activation and decreased force production of the quadriceps femoris muscle after total knee arthroplasty. Phys Ther. 2003 Apr;83(4):359-65.

  PMID: 12665406 BACKGROUND

• Rice DA, McNair PJ. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. Semin Arthritis Rheum. 2010 Dec;40(3):250-66. doi: 10.1016/j.semarthrit.2009.10.001. Epub 2009 Dec 2.

  PMID: 19954822 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

• Pua YH. The Time Course of Knee Swelling Post Total Knee Arthroplasty and Its Associations with Quadriceps Strength and Gait Speed. J Arthroplasty. 2015 Jul;30(7):1215-9. doi: 10.1016/j.arth.2015.02.010. Epub 2015 Feb 19.

  PMID: 25737387 BACKGROUND

• Snyder MA, Sympson AN, Scheuerman CM, Gregg JL, Hussain LR. Efficacy in Deep Vein Thrombosis Prevention With Extended Mechanical Compression Device Therapy and Prophylactic Aspirin Following Total Knee Arthroplasty: A Randomized Control Trial. J Arthroplasty. 2017 May;32(5):1478-1482. doi: 10.1016/j.arth.2016.12.027. Epub 2016 Dec 23.

  PMID: 28159420 BACKGROUND

• Pichonnaz C, Bassin JP, Lecureux E, Christe G, Currat D, Aminian K, Jolles BM. Effect of Manual Lymphatic Drainage After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 May;97(5):674-82. doi: 10.1016/j.apmr.2016.01.006. Epub 2016 Jan 30.

  PMID: 26829760 BACKGROUND

• Wouthuyzen-Bakker M, Lora-Tamayo J, Senneville E, Scarbourough M, Ferry T, Uckay I, Salles MJ, O'Connell K, Iribarren JA, Vigante D, Trebse R, Arvieux C, Soriano A, Ariza J; Group of Investigators for Streptococcal Prosthetic Joint Infection. Erysipelas or cellulitis with a prosthetic joint in situ. J Bone Jt Infect. 2018 Oct 4;3(4):222-225. doi: 10.7150/jbji.25519. eCollection 2018.

  PMID: 30416947 BACKGROUND

• Liu P, Mu X, Zhang Q, Liu Z, Wang W, Guo W. Should compression bandage be performed after total knee arthroplasty? A meta-analysis of randomized controlled trials. J Orthop Surg Res. 2020 Feb 14;15(1):52. doi: 10.1186/s13018-019-1527-9.

  PMID: 32059737 BACKGROUND

Study Officials

• Jason Jennings, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)