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

No longer recruiting at 4 trial locations

Overseen By Rachael A Kilkenny, MBA, BSN-RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Narcotics

Disqualifiers: DVT, Rheumatoid arthritis, Lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid recovery after knee replacement surgery. It compares a special knee sleeve, the Non-compressive Bioactive Garment, which uses infrared waves to reduce pain and swelling, with the usual tight socks (TED hose) that help with swelling and blood clots. The goal is to determine if the new sleeve can make recovery more comfortable and effective. Individuals who have had a single knee replaced and do not have conditions like rheumatoid arthritis or leg swelling problems may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods and enhance future patient care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a history of chronic narcotic use, you are excluded from participating.

What prior data suggests that the Reparel Knee Sleeve and TED Hose are safe for post-op recovery after knee surgery?

Research shows that the Non-Compressive Bioactive Garment (NCBG), such as the Reparel Knee Sleeve, is generally well-received by patients. Studies indicate it reduces pain and swelling after knee surgeries without causing major side effects. The garment reflects infrared waves back into the body, aiding recovery.

Previous research on patients with knee osteoarthritis suggests that the sleeve improves symptoms and overall function. These findings indicate the garment might be safe and effective for those recovering from knee surgery. Although no serious side effects have been reported, further research is needed to confirm these results for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves compression stockings like TED hose to manage post-op recovery after knee surgery, the non-compressive bioactive garment offers a unique approach. This garment reflects infrared waves generated by the body back into the soft tissue, potentially reducing pain and swelling without the need for compression. Researchers are excited about this treatment because it introduces a non-compressive method, which could offer a more comfortable recovery experience while still addressing inflammation and discomfort.

What evidence suggests that these treatments could be effective for post-op recovery after knee surgery?

Research shows that the Non-Compressive Bioactive Garment (NCBG), a treatment under study in this trial, can help reduce pain and swelling. Studies with similar bioactive sleeves have shown improvements in pain and movement for people with knee problems. For example, one study found that these garments reduced pain and improved movement in individuals with knee osteoarthritis. Another study demonstrated that bioactive sleeves effectively eased symptoms in conditions like tendinopathy, a painful tendon issue. These findings suggest that NCBG might relieve pain and aid recovery after knee surgery by reflecting infrared waves back into the surrounding tissue. ^{1 4 5 6 7}

Who Is on the Research Team?

Rachael A Kilkenney, MBA,BSN

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had a knee replacement with specific design features.

Exclusion Criteria

Allergy to silicone/polyester

I cannot follow the required after-surgery care and rehab plans.

I have been diagnosed with a type of inflammatory arthritis, such as rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Patients are recruited and consented in the office setting after non-operative modalities have been exhausted

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-operative

Patients undergo total knee arthroplasty and initial post-operative measurements are taken

1 day

1 visit (in-person)

Post-operative Treatment

Patients wear the assigned garment and track pain and narcotic use for 6 weeks

6 weeks

Daily self-reporting

Follow-up

Final range of motion and circumference measurements are obtained, and patients complete the Knee Society Score questionnaire

6 weeks

Regular intervals (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Non-compressive Bioactive Garment
• Thrombo-Embolic-Deterrent

Trial Overview

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.

How Is the Trial Designed?

Group I: Non-compressive Bioactive Garment Experimental Treatment 1 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 Deterrent Active Control 1 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.

Non-compressive Bioactive Garment is already approved in United States, Canada for the following indications:

Approved in United States as Reparel Knee Sleeve for:

• Post-operative swelling and pain management after total knee replacement

Approved in Canada as Reparel Knee Sleeve for:

• Post-operative swelling and pain management after total knee replacement

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

Covalent Bruton tyrosine kinase (BTK) inhibitors are effective treatments for relapsed mantle cell lymphoma (MCL), but patients may develop resistance, necessitating alternative therapies.

Recent advancements include anti-CD19 chimeric antigen receptor T-cell therapy and novel treatments like noncovalent BTK inhibitors and bispecific antibodies, providing new options for patients who progress after BTK inhibitor therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic options for relapsed/refractory mantle cell lymphoma. Eyre, TA., Cheah, CY., Wang, ML.[2023]

In a study involving 20 patients with relapsed grade II non-Hodgkin's lymphoma, the combination treatment of vindesine, etoposide, and prednisolone (VEP) resulted in a 40% overall response rate, with 20% achieving complete responses lasting 9 to 13+ months.

The treatment was associated with manageable side effects, primarily alopecia and myelosuppression, indicating that VEP is an effective second-line option for patients who have not responded to first-line therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vindesine, etoposide (VP-16), and prednisolone (VEP) in relapsed patients with grade II non-Hodgkin's lymphoma. Hancock, BW.[2013]

Romidepsin, a histone deacetylase inhibitor, has shown clinical efficacy in treating adult patients with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), with overall response rates of 34% for CTCL and 38% for PTCL in phase II trials involving patients with relapsed or refractory disease.

The treatment is generally well-tolerated, although it can cause significant hematological side effects such as leukopenia and thrombocytopenia, indicating that while effective, monitoring for these adverse events is important during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romidepsin: in the treatment of T-cell lymphoma. Yang, LP.[2021]

Incrediwear, a non-compressive sleeve designed to enhance blood flow, significantly reduced knee effusion compared to traditional compression stockings three weeks after total knee arthroplasty, with effusion levels dropping from 1.38 to 1.12 in the Incrediwear group versus an increase from 1.16 to 1.56 in the control group.

Patients using Incrediwear also experienced better knee flexion, with a decrease of only 3% in range of motion compared to a 7% decrease in the control group, indicating that Incrediwear may support better recovery outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. Justice, TE., Jacob, PB.[2023]

Compression garments (CGs) positioned around the whole knee (WK) improved knee joint position sense (JPS) in healthy adults, showing less variability in position sense compared to below-knee (BK) and control conditions.

The study involved 16 healthy young adults and found that while participants tended to underestimate their knee position in all conditions, the WK CG resulted in a significantly larger negative error, indicating a specific effect of CG positioning on knee JPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of compression garment around the knee affects healthy adults' knee joint position sense acuity. Zhang, LY., Négyesi, J., Okuyama, T., et al.[2020]

A compression bandage applied from the toes to mid-thigh generates sufficient pressure (28-32 mm Hg) to effectively control bleeding in the knee joint after replacement surgery, achieving the necessary tamponade pressure (52-62 mm Hg) to prevent complications.

Patients using compression bandaging experienced faster recovery, shorter hospital stays, greater knee flexion at discharge, and fewer complications compared to those using a standard crêpe bandage, highlighting the benefits of this method in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bandaging technique after knee replacement. Charalambides, C., Beer, M., Melhuish, J., et al.[2009]

In a study involving 36 healthy young adults, the use of a neoprene sleeve improved knee joint position sense more significantly during a sitting open kinetic chain test (1.2 degrees) compared to a supine closed kinetic chain test (0.3 degrees).

Despite the small improvements in joint angle replication, 72% of participants reported feeling that the sleeve enhanced their overall performance, indicating potential subjective benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a neoprene sleeve on knee joint position sense during sitting open kinetic chain and supine closed kinetic chain tests. Birmingham, TB., Kramer, JF., Inglis, JT., et al.[2022]

In a study of 88 patients who underwent total knee arthroplasty, the use of medical elastic compression stockings did not significantly reduce knee, calf, or ankle swelling compared to no stockings over a 4-week period.

There was no difference in pain levels or patient-reported knee function between those who used the stockings and those who did not, indicating that the stockings may not provide clinical benefits after this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of compression therapy on knee swelling and pain after total knee arthroplasty. Munk, S., Jensen, NJ., Andersen, I., et al.[2021]

Romidepsin, a histone deacetylase inhibitor, shows significant clinical activity in patients with relapsed peripheral T-cell lymphoma (PTCL), achieving an overall response rate of 38% in a phase 2 trial involving 45 patients.

The treatment resulted in durable responses, with a median duration of response lasting 8.9 months, indicating its potential effectiveness even in patients with a history of multiple prior therapies, including stem-cell transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Piekarz, RL., Frye, R., Prince, HM., et al.[2021]

In a small study of 7 heavily pretreated patients with relapsed/refractory peripheral T cell lymphoma (PTCL), the combination of romidepsin and bendamustine showed promising results, with 2 patients achieving complete remission and one maintaining progression-free survival for over 4 years.

The treatment was associated with minimal toxicity, with no treatment-related deaths or discontinuations, although over 50% of patients experienced significant nausea and vomiting, indicating a need for further investigation into this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Romidepsin-Bendamustine Combination for Relapsed/Refractory T Cell Lymphoma. Nachmias, B., Shaulov, A., Lavie, D., et al.[2019]

The use of graded-pressure elastic hose (TED Stockings) significantly reduces the risk of deep venous thrombosis and pulmonary embolism in high-risk, bedridden postoperative patients, as shown by a trial with positive results.

The study was conducted using a closed sequential program, which adds rigor to the findings, confirming the efficacy of TED Stockings in preventing these serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Graduated and constant compression of the lower extremities in the prevention of postoperative deep venous thrombosis and of pulmonary thromboembolism. Clinical trial]. Polto, F., Musumeci, S., Vadalà, G., et al.[2009]

A large randomized controlled trial (RCT) involving 2600 adult patients will assess the efficacy of short-stretch compression bandages compared to standard bandaging after total knee arthroplasty, aiming to detect a significant improvement in patient-reported outcomes at 52 weeks.

The study will evaluate multiple outcomes, including knee pain and function (measured by the Oxford Knee Score), quality of life (EQ-5D scores), and complications, contributing valuable data to guide clinical practices in post-surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. Cook, L., Northgraves, MJ., Fairhurst, C., et al.[2020]

In a study of 84 patients who underwent total knee arthroplasty, there were no significant differences in recovery outcomes between those using compression bandaging and those using cold therapy with cryo-pad technology.

Compression bandaging was found to be more cost-effective and labor-efficient compared to cryo-pad technology, suggesting it may be a preferable option for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial comparing compression bandaging and cold therapy in postoperative total knee replacement surgery. Smith, J., Stevens, J., Taylor, M., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04751942?term=AREA%5BConditionSearch%5D(Knee)&rank=10

Reparel Knee Sleeve vs. TED Hose for Post-op Swelling ...

This prospective study will evaluate pain, swelling, ROM as well as narcotic use in post-operative total knee arthroplasty patients using novel ...

2.

momayamd.com

momayamd.com/pdf/bioactive-knee-sleeve-for-osteoarthritis-updated.pdf

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ...

Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee. OA. Further research ...

3.

journaloei.scholasticahq.com

journaloei.scholasticahq.com/article/121294-investigating-the-efficacy-of-bioactive-sleeves-with-embedded-nano-semiconductors-in-alleviating-tendinopathy-an-in-vivo-pilot-study

Investigating the Efficacy of Bioactive Sleeves with Embedded ...

The results of our study indicate that application of bioactive nano-semiconductor sleeves had a significant effect in alleviating Achilles tendinopathy.

4.

withpower.com

withpower.com/trial/phase-osteoarthritis-knee-4-2021-f4393

Reparel™ Knee Sleeve for Osteoarthritis

This trial is testing a special knee brace called the Reparel™ knee sleeve, which uses heat to help reduce pain and improve movement in people with knee ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04743921

Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis

This investigation will examine this non-operative treatment modality and study it effect for the treatment of knee OA specifically by investigating the Reparel ...

6.

reparel.com

reparel.com/product/knee-sleeve/

Knee Sleeve – Arthritis Pain Relief & Post-Op Recovery

Reparel Knee Sleeve reduces arthritis pain, post-surgical swelling, and inflammation. Clinically backed, non-pharma recovery support for active patients.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36191914/

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ...

Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee OA. Further research is ...