Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21 participants
INTERVENTIONAL
2021-04-01
2022-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Swelling Management After Knee Replacement
NCT06095401
Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty
NCT03490409
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
NCT03521869
Compression Bandage in Local Infiltration Analgesia Afte Total Knee Arthroplasty
NCT00485212
Nurse Led Follow-up After Total Knee Arthroplasty
NCT01771315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specific Aim 1:
Estimate the effect of immediate compression garment (ICG) on the primary outcome of swelling at 4 days and 1, 2, 3, and 6 weeks postoperative.
Hypothesis: The ICG group will have less swelling at 4 days and 1, 2, 3, and 6 weeks postoperative compared to historical controls.
Specific Aim 2:
Determine the participant feasibility of ICG by assessing 1) satisfaction and 2) adherence.
Hypothesis 3.1: Study participants will indicate acceptability of compression garment wear with a median score of at least 4/5 ("somewhat satisfied") on a 5-point Likert scale satisfaction survey.
Hypothesis 3.2: An 80% adherence rate will be observed for compression garment wear as assessed by a patient log.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ICG
Immediate Compression Garment
Immediate Compression Garment
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate Compression Garment
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Colorado Joint Replacement
OTHER
medi
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jason Jennings, MD
Role: PRINCIPAL_INVESTIGATOR
Colorado Joint Replacement
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colorado Joint Replacement
Denver, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Huang CH, Cheng CK, Lee YT, Lee KS. Muscle strength after successful total knee replacement: a 6- to 13-year followup. Clin Orthop Relat Res. 1996 Jul;(328):147-54. doi: 10.1097/00003086-199607000-00023.
Rantanen T, Guralnik JM, Izmirlian G, Williamson JD, Simonsick EM, Ferrucci L, Fried LP. Association of muscle strength with maximum walking speed in disabled older women. Am J Phys Med Rehabil. 1998 Jul-Aug;77(4):299-305. doi: 10.1097/00002060-199807000-00008.
Skelton DA, Greig CA, Davies JM, Young A. Strength, power and related functional ability of healthy people aged 65-89 years. Age Ageing. 1994 Sep;23(5):371-7. doi: 10.1093/ageing/23.5.371.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1722208-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.