Arthroscopic Surgical ProceduresNCT06240780
Incrediwear ACL MCL Arthroscopic Surgery Recovery Study
A study testing Activated Incrediwear Products in people with Arthroscopic Surgical Procedures and Anterior Cruciate Ligament Reconstruction, run by Oklahoma Joint Reconstruction Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscopic Surgical Procedures, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Activated Incrediwear Products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consented to protocol
- Compliant to protocol
- BMI less than 35
- Undergoing ACL or ACL+MCL within 30 days
Who cannot join
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
- Pain management patient
Show all 9Show fewer
- Prior knee surgery to the operative / study knee
- Worker's Comp patients
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oklahoma Joint Reconstruction Institute
Oklahoma City, Oklahoma, 73114
About this study
Official title: A Randomized Prospective Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Participant population includes female or male patients in relative good health, 18 to 65 years old. The investigators will compare participants with Incrediwear and placebo Incrediwear products during the first 6-month postoperative period. The main question it aims to answer are:
- Will the Incrediwear products help participants to decrease postoperative pain and swelling?
- Will the Incrediwear products help the participants by increasing the range of motion in a shorter amount of time than the placebo group? Participants will be asked to maintain a journal documenting surgical site pain, pain medication type and quantity taken.
Read more
Researcher will compare 90 participants enrolled in one of six groups, double blinded and randomly assigned, to see if the Incrediwear products assist in controlling postoperative swelling, and increase range of motion in a shorter amount of time.
- ACL participants randomly assigned the Incrediwear product, placebo product, or none
- ACL+MCL participants randomly assigned the Incrediwear product, placebo product, or none
Read the detailed description
Researcher will identify patients of the Primary Investigator (PI) who are candidate for the study. Subjects must otherwise be in good health as determined by medical history, physical examination, vital signs, and applicable laboratory tests and receive medical clearance for the procedure by the PI.
Subjects must be able to read and sign an informed consent form indicating understand the purpose of, and the procedures required for the study, and are willing to participate and comply with the study protocol.
This will be a prospective study to evaluate the benefit of the Incrediwear product after ACL repair or ACL+MCL repair via arthroscopic surgery. Subjects who fit the inclusion and exclusion criteria will be reviewed on a subject-by-subject basis at the time of informed consent documentation.
Preoperative and Post-Operative Measurements:
Subjective: Participants rates surgical site pain, on a 0-10 Visual Analogue Scale (VAS) pain scale.
Participants will record pain medication type and quantity taken in a daily pain diary.
Objective: Surgical extremity range of motion, and surgical extremity knee effusion.
Measurements will be taken at; Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month).
After the surgery, the participant will be placed in the study provided Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock. The Participant will wear the products at all times, for a minimum of 23 hours per day, for days 1 through 30.
At day 31, the participant will wear the leg sleeve at night, knee sleeve during the day, and is no longer required to wear the Incrediwear sock, until day 180.
At the 6 month postoperative appointment, the participant will turn in the patient journal.
- Being tested
- Activated Incrediwear Products, Sham Incrediwear Products
- Keywords
- Arthroscopic Surgical Procedures, Anterior Cruciate Ligament Reconstruction, Medial Collateral Ligament Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated Incrediwear ProductsOther
Activated Incrediwear products incorporates semiconductor elements within the fabric that releases negative ions when stimulated by body heat. The negative ions activate cellular vibrations that increase blood flow and circulation.
Sham Incrediwear ProductsOther
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
| Study group | Role | What they receive |
|---|---|---|
| ACL Arthroscopic Active Participants | Active comparator | After the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. Receives: Other: Activated Incrediwear Products |
| ACL Arthroscopic Placebo Participants | Placebo comparator | After the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. Receives: Other: Sham Incrediwear Products |
| ACL Arthroscopic Stand of Care Participants | No intervention | After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days. |
| ACL + MCL Arthroscopic Active Participants | Active comparator | After the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. Receives: Other: Activated Incrediwear Products |
| ACL + MCL Arthroscopic Placebo Participants | Placebo comparator | After the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. Receives: Other: Sham Incrediwear Products |
| ACL + MCL Arthroscopic Stand of Care Participants | No intervention | After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Patient Pain Experience
The Visual Analogue Scale (VAS), a 0 to 10 scale, with 0 being no pain and 10 being the worst pain will be used to measures pain intensity.
Measured: 180 days
Pain Medication Usage
Patient will document pain medication type and quantity taken in a daily pain diary.
Measured: 180 days
Effusion/swelling Measurements
The Patella sweep test is used to measure effusion. The measured rating is a quantity on a scale of 0 to 3, with 0 rating no fluid-wave while perorming a downward stroke, 1 a large bulge, 2 medial fluid returns to position without performing a downward sweep, and 3 excell of fluid that makes it impossible to stroke the medial fluid away. Measurements will be taken at set times during the postoperative period.
Measured: 180 days
Range of Motion
The patient's range of motion captured at all time points during the postoperative period.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start30 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- . Participants will randomly be assigned treatment type in addition to the standard of care procedure they will be instructed to follow (active vs. placebo vs standard of care alone) based on surgery type. An equal number of patients from each primary condition type (ACL or ACL+MCL) will be assigned to each treatment type.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma Joint Reconstruction Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garrett Steinmetz, MD, Principal investigator, Oklahoma Joint Reconstruction Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240780
- Sponsor's protocol ID
- 2023-04
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT06240780
- Acronym / sponsor ID
- 2023-04
- Keywords
- Arthroscopic Surgical Procedures, Anterior Cruciate Ligament Reconstruction, Medial Collateral Ligament Reconstruction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Oklahoma Joint Reconstruction InstituteUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Participant population includes female or male patients in relative good health, 18 to 65 years old. The investigators will compare participants with Incrediwear and placebo Incrediwear products during the first 6-month postoperative period. The main question it aims to answer are:
- Will the Incrediwear products help participants to decrease postoperative pain and swelling?
- Will the Incrediwear products help the participants by increasing the range of motion in a shorter amount of time than the placebo group? Participants will be asked to maintain a journal documenting surgical site pain, pain medication type and quantity taken.
Researcher will compare 90 participants enrolled in one of six groups, double blinded and randomly assigned, to see if the Incrediwear products assist in controlling postoperative swelling, and increase range of motion in a shorter amount of time.
- ACL participants randomly assigned the Incrediwear product, placebo product, or none
- ACL+MCL participants randomly assigned the Incrediwear product, placebo product, or none
Detailed description
Researcher will identify patients of the Primary Investigator (PI) who are candidate for the study. Subjects must otherwise be in good health as determined by medical history, physical examination, vital signs, and applicable laboratory tests and receive medical clearance for the procedure by the PI.
Subjects must be able to read and sign an informed consent form indicating understand the purpose of, and the procedures required for the study, and are willing to participate and comply with the study protocol.
This will be a prospective study to evaluate the benefit of the Incrediwear product after ACL repair or ACL+MCL repair via arthroscopic surgery. Subjects who fit the inclusion and exclusion criteria will be reviewed on a subject-by-subject basis at the time of informed consent documentation.
Preoperative and Post-Operative Measurements:
Subjective: Participants rates surgical site pain, on a 0-10 Visual Analogue Scale (VAS) pain scale.
Participants will record pain medication type and quantity taken in a daily pain diary.
Objective: Surgical extremity range of motion, and surgical extremity knee effusion.
Measurements will be taken at; Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month).
After the surgery, the participant will be placed in the study provided Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock. The Participant will wear the products at all times, for a minimum of 23 hours per day, for days 1 through 30.
At day 31, the participant will wear the leg sleeve at night, knee sleeve during the day, and is no longer required to wear the Incrediwear sock, until day 180.
At the 6 month postoperative appointment, the participant will turn in the patient journal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- . Participants will randomly be assigned treatment type in addition to the standard of care procedure they will be instructed to follow (active vs. placebo vs standard of care alone) based on surgery type. An equal number of patients from each primary condition type (ACL or ACL+MCL) will be assigned to each treatment type.
| Arm | Type | Receives |
|---|---|---|
| ACL Arthroscopic Active Participants | Active comparator | Other: Activated Incrediwear ProductsAfter the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. |
| ACL Arthroscopic Placebo Participants | Placebo comparator | Other: Sham Incrediwear ProductsAfter the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. |
| ACL Arthroscopic Stand of Care Participants | No intervention | –After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days. |
| ACL + MCL Arthroscopic Active Participants | Active comparator | Other: Activated Incrediwear ProductsAfter the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. |
| ACL + MCL Arthroscopic Placebo Participants | Placebo comparator | Other: Sham Incrediwear ProductsAfter the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve. |
| ACL + MCL Arthroscopic Stand of Care Participants | No intervention | –After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consented to protocol
- Compliant to protocol
- BMI less than 35
- Undergoing ACL or ACL+MCL within 30 days
Key exclusion criteria (9 listed)
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Incrediwear ProductsActivated Incrediwear products incorporates semiconductor elements within the fabric that releases negative ions when stimulated by body heat. The negative ions activate cellular vibrations that increase blood flow and circulation. | Other | ACL + MCL Arthroscopic Active Participants, ACL Arthroscopic Active Participants |
| Sham Incrediwear ProductsSimple fabric Incrediwear products that do not include the semiconductor elements within the fabric. | Other | ACL + MCL Arthroscopic Placebo Participants, ACL Arthroscopic Placebo Participants |
Primary outcome
Subjective Patient Pain Experience
Time frame: 180 days
The Visual Analogue Scale (VAS), a 0 to 10 scale, with 0 being no pain and 10 being the worst pain will be used to measures pain intensity.
Pain Medication Usage
Time frame: 180 days
Patient will document pain medication type and quantity taken in a daily pain diary.
Effusion/swelling Measurements
Time frame: 180 days
The Patella sweep test is used to measure effusion. The measured rating is a quantity on a scale of 0 to 3, with 0 rating no fluid-wave while perorming a downward stroke, 1 a large bulge, 2 medial fluid returns to position without performing a downward sweep, and 3 excell of fluid that makes it impossible to stroke the medial fluid away. Measurements will be taken at set times during the postoperative period.
Range of Motion
Time frame: 180 days
The patient's range of motion captured at all time points during the postoperative period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Current and past research information regarding the Incrediwear products.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
Related trials for Arthroscopic Surgical Procedures
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
RecruitingObservational study
SPSIP Block in Shoulder Artroscopy
Shoulder Arthroscopic Surgeries
Not yet recruitingPhase 4
Exparel and Dexamethasone
Postoperative Pain, Shoulder Arthroscopic Surgeries
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Garrett Steinmetz, MD principal investigator
Oklahoma Joint Reconstruction Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated Incrediwear Products in people with Arthroscopic Surgical Procedures and Anterior Cruciate Ligament Reconstruction, run by Oklahoma Joint Reconstruction Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Patient Pain Experience (time frame: 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.