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

Recruiting in Bedford (>99 mi)

+4 other 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

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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 safety data exists for Reparel Knee Sleeve and TED Hose after knee surgery?

The safety data for Reparel Knee Sleeve, also known as Non-compressive Bioactive Garment, is limited but includes a pilot study comparing it to compression stockings after total knee arthroplasty, suggesting it may enhance blood flow. For TED Hose, or Thrombo-Embolic-Deterrent Stockings, there is clinical trial data showing they are effective in preventing deep venous thrombosis and pulmonary embolism in high-risk postoperative patients. ^{1 2 3 4 5}

Is the Reparel Knee Sleeve a promising treatment for post-op recovery after knee surgery?

The information provided does not include any details about the Reparel Knee Sleeve or its effectiveness as a treatment for post-op recovery after knee surgery. Therefore, we cannot determine if it is a promising treatment based on the given data. ^{6 7 8 9 10}

What data supports the idea that Reparel Knee Sleeve vs. TED Hose for Post-Op Recovery After Knee Surgery is an effective treatment?

The available research shows that non-compressive sleeves, like the Reparel Knee Sleeve, are designed to enhance blood flow, which can be beneficial after knee surgery. While compression stockings are commonly used, the study comparing these two options suggests that the Reparel Knee Sleeve might offer similar benefits in terms of improving blood flow without the compression. However, the research does not provide specific data on the effectiveness of the Reparel Knee Sleeve compared to TED Hose for post-op recovery. Other studies mentioned focus on different aspects, such as knee joint position sense and the effects of compression therapy on swelling and pain, but they do not directly compare the Reparel Knee Sleeve to TED Hose for post-op recovery. ^{1 2 11 12 13}

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

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]

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]

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]

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]

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 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]

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]

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 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]

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]

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]

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]

Citations

1. India pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of compression therapy on knee swelling and pain after total knee arthroplasty. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial comparing compression bandaging and cold therapy in postoperative total knee replacement surgery. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Position of compression garment around the knee affects healthy adults' knee joint position sense acuity. [2020]

6. Italy 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]. [2009]

7. Sweden pubmed.ncbi.nlm.nih.gov

Bandaging technique after knee replacement. [2009]

8. England 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Romidepsin-Bendamustine Combination for Relapsed/Refractory T Cell Lymphoma. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Therapeutic options for relapsed/refractory mantle cell lymphoma. [2023]