Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, Pain and Range of Motion After Total Knee Replacement

NCT04751942 | Completed Results FDA Device

• 1 other identifier: STUDY20210037
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study will evaluate pain, swelling, ROM as well as narcotic use in post-operative total knee arthroplasty patients using novel Non-Compressive Bioactive Garment (NCBG) versus current standard of care gradient compression stocking (Thrombo-Embolic-Deterrent or TED hose). If NCBG proves to be more effective in these outcome areas, it will provide a new and comfortable way to reduce patient pain and swelling immediately following surgery

Conditions

Osteoarthritis Knees Both

Keywords

post-operative swelling; total knee arthroplasty; TKA; TED hose; photobiomodulation

Outcome Measures

Primary Outcomes (5)

• Change in Leg Circumference (cm)

  circumference of the leg will be measured pre-operatively, immediately post operatively, and at regular intervals post-operatively.

  Preop, 2 weeks post op, 6 weeks post-op, 3 months post-op

• Change in Pain Score (1-10)

  patient's subjective pain scores will be recorded daily in a pain journal using a visual analog scale from 1-10, values are grouped into mild (1-3), moderate (4-6), and severe (7-10) pain.

  Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

• Change in Range of Motion

  patients passive flexion range of motion will be tested pre-operatively, immediately post-operatively, and at regular intervals post-operatively

  Pre-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

• Change in Narcotic Consumption

  the narcotic consumption in Milligrams of morphine equivalents (MME) per day will be recorded post-operatively while in the hospital and will be self reported by the patient in a journal as "number of pills" taken

  1 week Post-op, 2 weeks Post-op. 6 weeks Post-op, 3 months Post-op

• Change in Knee Society Score (KSS)

  a validated system that combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. Patients will fill out this questionnaire pre-operatively and at each post-operative visit. With lower scores indicating lower pain/difficulty with daily activities and higher scores indicating higher pain/difficulty with daily activities.

  Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

Study Arms (2)

Non-compressive Bioactive Garment

EXPERIMENTAL

The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.

Device: Non-compressive Bioactive Garment

Thrombo-Embolic Deterrent

ACTIVE COMPARATOR

a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.

Device: thrombo-embolic deterrent

Interventions

Non-compressive Bioactive Garment DEVICE

patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty

Non-compressive Bioactive Garment

thrombo-embolic deterrent DEVICE

patients will be randomized to wear the gold standard TED hose following total knee arthroplasty

Also known as: TED hose

Thrombo-Embolic Deterrent

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral Total Knee Replacement - Cruciate retaining and Posterior stabilized designs

You may not qualify if:

• Leg circumference \> 23 in.
• Allergy to silicone/polyester
• Current DVT
• Primary Inflammatory Type arthritis (i.e. rheumatoid arthritis)
• Inability to follow standardized post op and rehab protocols
• Lymphedema
• History of Vascular Bypass Surgery on Operative Limb (i.e. Fem-Pop or Fem-Fem)
• Chronic Narcotic Use History

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Beachwood Medical Center

Beachwood, Ohio, 44122, United States

Location

Related Publications (13)

• Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.

  PMID: 16967035 BACKGROUND

• Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.

  PMID: 3403614 BACKGROUND

• Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.

  PMID: 21044725 BACKGROUND

• Spencer JD, Hayes KC, Alexander IJ. Knee joint effusion and quadriceps reflex inhibition in man. Arch Phys Med Rehabil. 1984 Apr;65(4):171-7.

  PMID: 6712434 BACKGROUND

• Hopkins JT, Ingersoll CD, Krause BA, Edwards JE, Cordova ML. Effect of knee joint effusion on quadriceps and soleus motoneuron pool excitability. Med Sci Sports Exerc. 2001 Jan;33(1):123-6. doi: 10.1097/00005768-200101000-00019.

  PMID: 11194097 BACKGROUND

• McNair PJ, Marshall RN, Maguire K. Swelling of the knee joint: effects of exercise on quadriceps muscle strength. Arch Phys Med Rehabil. 1996 Sep;77(9):896-9. doi: 10.1016/s0003-9993(96)90277-4.

  PMID: 8822681 BACKGROUND

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Bowling K, Ratcliffe C, Townsend J, Kirkpatrick U. Clinical thromboembolic detterrent stockings application: are thromboembolic detterrent stockings in practice matching manufacturers application guidelines. Phlebology. 2015 Apr;30(3):200-3. doi: 10.1177/0268355514542843. Epub 2014 Jul 2.

  PMID: 24990877 BACKGROUND

• Munk S, Jensen NJ, Andersen I, Kehlet H, Hansen TB. Effect of compression therapy on knee swelling and pain after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):388-92. doi: 10.1007/s00167-012-1963-0. Epub 2012 Mar 28.

  PMID: 22453307 BACKGROUND

• Ross M, Worrell TW. Thigh and calf girth following knee injury and surgery. J Orthop Sports Phys Ther. 1998 Jan;27(1):9-15. doi: 10.2519/jospt.1998.27.1.9.

  PMID: 9440035 BACKGROUND

• Smith J, Stevens J, Taylor M, Tibbey J. A randomized, controlled trial comparing compression bandaging and cold therapy in postoperative total knee replacement surgery. Orthop Nurs. 2002 Mar-Apr;21(2):61-6. doi: 10.1097/00006416-200203000-00009.

  PMID: 11949239 BACKGROUND

• de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016 May-Jun;22(3):7000417. doi: 10.1109/JSTQE.2016.2561201.

  PMID: 28070154 BACKGROUND

• Karu TI. Mitochondrial signaling in mammalian cells activated by red and near-IR radiation. Photochem Photobiol. 2008 Sep-Oct;84(5):1091-9. doi: 10.1111/j.1751-1097.2008.00394.x. Epub 2008 Jul 18.

  PMID: 18651871 BACKGROUND

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Limitations and Caveats

Limitations to this study included the mid-study employment change of Corey Barnett, who had served as a primary data collection specialist. In addition, a transition to a new electronic medical record system within the practice introduced added complexity in monitoring patients both pre- and postoperatively.

Results Point of Contact

• Title: Rachael Kilkenny
• Organization: Univeristy Hosptials Cleveland Medical Center

Rachael.Kilkenny@UHhosptials.org

216-545-4850

Study Officials

• Rachael A Kilkenney, MBA,BSN

  University Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Program Coordinator

Model Details: prospective randomized control cohort study

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: October 20, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)