← Back to Search

Device

Reparel Knee Sleeve vs. TED Hose for Post-Op Recovery After Knee Surgery

N/A

Recruiting

Led By Rachael A Kilkenney, MBA,BSN

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will compare a new kind of post-operative garment to the current standard to see if it is more effective in reducing pain, swelling, and range of motion, as well as the need for narcotics.

Who is the study for?

This trial is for individuals who have had a total knee replacement due to osteoarthritis. They must be able to follow post-op and rehab protocols, without a history of deep vein thrombosis (DVT), vascular bypass surgery on the operative limb, lymphedema, chronic narcotic use, or leg circumference over 23 inches. Those with primary inflammatory arthritis or allergies to silicone/polyester cannot join.Check my eligibility

What is being tested?

The study compares two methods for managing post-operative symptoms after knee replacement: a Non-Compressive Bioactive Garment (NCBG) versus standard compression stockings (TED hose). It will assess which is better at reducing pain, swelling, range of motion limitations and the need for narcotics.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the garments or skin reactions in case of sensitivity to garment materials like silicone or polyester. However, these are generally considered safe interventions with minimal risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a knee replacement with specific design features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Score (1-10)

knee society score (KSS)

leg circumference (cm)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-compressive Bioactive GarmentExperimental Treatment1 Intervention

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.

Group II: Thrombo-Embolic DeterrentActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

318 Previous Clinical Trials

339,985 Total Patients Enrolled

5 Trials studying Osteoarthritis

229 Patients Enrolled for Osteoarthritis

Rachael A Kilkenney, MBA,BSNPrincipal InvestigatorUniversity Hospitals

Media Library

Non-compressive Bioactive Garment (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04751942 — N/A

Osteoarthritis Research Study Groups: Non-compressive Bioactive Garment, Thrombo-Embolic Deterrent

Osteoarthritis Clinical Trial 2023: Non-compressive Bioactive Garment Highlights & Side Effects. Trial Name: NCT04751942 — N/A

Non-compressive Bioactive Garment (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751942 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this experiment?

"There are 4 recruiting sites for this trial, namely University Hospitals Geauga Medical Center in Chardon, University Hospitals Richmond Medical Center in Richmond Heights, and University Hospitals Bedford Medical Center in Bedford. An additional four locations are also participating."

Answered by AI

Is the eligibility threshold for this research experiment restricted to those under 30 years of age?

"This clinical investigation will only consider participants between 18 and 89 years of age. For those younger than this, there are 27 separate trials available, whereas 433 studies exist for individuals over 65."

Answered by AI

Are there any vacancies open to prospective patients in this experiment?

"The clinicaltrials.gov records indicate that the recruitment for this medical trial is closed, as it was last updated on November 7th 2022 after being first posted on December 1st of the same year. Nevertheless, there are currently 456 other studies actively recruiting patients."

Answered by AI

Who is the ideal candidate to join this trial?

"This clinical study requires the recruitment of 100 participants between 18 and 89 who have been diagnosed with osteoarthritis in their knee. In addition, patients must meet additional requirements such as having undergone a primary unilateral total knee replacement performed either via cruciate retaining or posterior stabilized designs."

Answered by AI

Recent research and studies

Archives of Physical Medicine and RehabilitationJournal

Swelling of the Knee Joint: Effects of Exercise on Quadriceps Muscle Strength

McNair, Peter J., Robert N. Marshall, and Ken Maguire. 1996. “Swelling of the Knee Joint: Effects of Exercise on Quadriceps Muscle Strength”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/s0003-9993(96)90277-4.

Journal of Neuroscience MethodsJournal

Soleus and Vastus Medialis H-reflexes: Similarities and Differences While Standing or Lying During Varied Knee Flexion Angles

Alrowayeh, Hesham N., Mohamed A. Sabbahi, and Bruce Etnyre. 2005. “Soleus and Vastus Medialis H-reflexes: Similarities and Differences While Standing or Lying During Varied Knee Flexion Angles”. Journal of Neuroscience Methods. Elsevier BV. doi:10.1016/j.jneumeth.2004.11.011.

Medicine and Science in Sports and ExerciseJournal

Effect of Knee Joint Effusion on Quadriceps and Soleus Motoneuron Pool Excitability

HOPKINS, JON T., CHRISTOPHER D. INGERSOLL, B. ANDREW KRAUSE, JEFFREY E. EDWARDS, and MITCHELL L. CORDOVA. 2001. “Effect of Knee Joint Effusion on Quadriceps and Soleus Motoneuron Pool Excitability”. Medicine and Science in Sports and Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005768-200101000-00019.

Knee Surgery, Sports Traumatology, ArthroscopyJournal