Reparel Knee Sleeve vs. TED Hose for Post-Op Recovery After Knee Surgery
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.12345Why 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.14567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Patients are recruited and consented in the office setting after non-operative modalities have been exhausted
Surgery and Immediate Post-operative
Patients undergo total knee arthroplasty and initial post-operative measurements are taken
Post-operative Treatment
Patients wear the assigned garment and track pain and narcotic use for 6 weeks
Follow-up
Final range of motion and circumference measurements are obtained, and patients complete the Knee Society Score questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Non-compressive Bioactive Garment
- Thrombo-Embolic-Deterrent
Non-compressive Bioactive Garment is already approved in United States, Canada for the following indications:
- Post-operative swelling and pain management after total knee replacement
- Post-operative swelling and pain management after total knee replacement
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor