Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| INCREDIWEAR HOLDINGS, INC. | INDUSTRY |
Not provided
Not provided
Not provided
The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) arthroscopic surgery. The effect of the sleeves will be analyzed through patient reported and clinically measured outcomes. The main questions it aims to answer are:
Researchers will compare semiconductor fabric sleeves to a placebo (a look-alike sleeve that contains no semiconductor material) to see if the semiconductor fabric better treats ACL and ACL+meniscus surgical patients.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | This arm of the study involves the control group who will receive the standard of care. | |
| Semiconducting Fabric Sleeve Group | Active Comparator | This group will be receiving semiconducting fabric sleeve to be worn post-operatively. |
|
| Placebo Group | Placebo Comparator | This group receives a look-alike sleeve that contains no semiconductor material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semiconducting fabric sleeves | Device | This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effusion Measurements | Effusion is measured by taking the circumference using a soft measuring tape at the following points:
| 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronak M Patel, MD | Contact | 6309292249 | rpatel@ibji.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Bone and Joint Institute | Recruiting | Westmont | Illinois | 60559 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36622554 | Background | O'Riordan SF, Bishop DJ, Halson SL, Broatch JR. Do Sports Compression Garments Alter Measures of Peripheral Blood Flow? A Systematic Review with Meta-Analysis. Sports Med. 2023 Feb;53(2):481-501. doi: 10.1007/s40279-022-01774-0. Epub 2023 Jan 9. | |
| 26014120 | Background | Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-semiconducting fabric sleeves | Device | This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively. |
|
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | Visual Analog Scale (VAS) - assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity. | 1 year |
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities | 1 year |
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | Knee Single Assessment Numeric Evaluation (SANE) - assess knee function on a scale of 0 to 100, with 100 representing normal function | 1 year |
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | Tegner Activity Scale - assesses work/sport activities level on a scale of 0 to 10, with 0 representing sick leave and 10 representing elite competitive sports. | 1 year |
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | Lysholm Scale - assesses pain, instability, locking, swelling, limp, stair-climbing, squatting, and use of support after ligament surgery on a scale of 0 to 100. | 1 year |
| Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires | Knee injury and Osteoarthritis Outcome Score Jr (KOOS Jr) - assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems | 1 year |
| 38094981 | Background | Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar. |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided