CompletedNot Applicable

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

United States23 participantsStarted 2023-10-20

Plain-language 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

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary unilateral Total Knee Replacement - Cruciate retaining and Posterior stabilized designs Exclusion Criteria: * 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

What they're measuring

Change in Leg Circumference (cm)

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

Change in Pain Score (1-10)

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

Change in Range of Motion

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

Change in Narcotic Consumption

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

Change in Knee Society Score (KSS)

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

Trial details

NCT IDNCT04751942

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-21

Results submitted2025-09-17

View on ClinicalTrials.gov More Osteoarthritis Knees Both trials

Plain-language summary

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Leg Circumference (cm)

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

Change in Pain Score (1-10)

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

Change in Range of Motion

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

Change in Narcotic Consumption

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

Change in Knee Society Score (KSS)

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