Anterior Cruciate Ligament TearNCT06668376
A Study to Evaluate the Incrediwear Products Immediately After ACL Repair
A study testing Leg Sleeve in people with Anterior Cruciate Ligament Tear and Medial Collateral Ligament, run by Texas Bone and Joint at 1 site in United States.
Trial summary
To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of motion and effusion. The study team will compare patients with Incrediwear products, or placebo Incrediwear products, or no products during the first 6-month postoperative… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Medial Collateral Ligament
- What is being tested?
- Leg Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 protocol
- BMI less than 35
- Undergoing ACL or ACL+MCL within 30 days
Who cannot join
- Pregnancy
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
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- Pain management patient
- Prior knee surgery to the operative / study knee
- Worker's Comp patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of motion and effusion. The study team will compare patients with Incrediwear products, or placebo Incrediwear products, or no products during the first 6-month postoperative period. The group that does not wear the Incrediwear or placebo products is considered the standard of care control group and will proceed with the normal standard of care compression hose.
Read the detailed description
After knee surgery, the participant will be randomly assigned to one of the three groups. The participant will have a 1-in-3 chance of being assigned to each group. The products will be placed on the participant by the hospital staff according to the random assignment sent with the surgical packet.
Study Screening/pre-operative appointment
- The surgeon confirms the participant meets the inclusion criteria and are scheduled for surgery in the next few weeks, and how the participant may be eligible to participate in the study.
- The surgeon will discuss the study and possible risks/benefits of being in the research.
- Day of surgery
- The study packet will be sent to the hospital by the clinical staff. The packet will include a study number assignment, the products assigned the study number, and the patient study journal. The participant, surgeon, and hospital staff will not know which group the participant are in, with the exception of the standard of care control group, as this group will wear the hospital-issued compression hose.
- Postoperative Recovery
- Subjective: Patient rates surgical site pain, on a 0-10 VAS pain scale. Patients will record pain medication type and quantity taken in a daily pain diary.
- Objective: Surgical extremity range of motion, and surgical extremity knee effusion, measured by either the Physical Therapist or the surgeon at the postop appointment.
- 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).
- Being tested
- Leg Sleeve, Placebo
- Keywords
- Anterior Cruciate Ligament Tear, Medial Collateral Ligament Tear, Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Arthroscopic surgery
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg SleeveDevice
Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) and given instructions. 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. The study will be double blinded as to the active vs placebo groups.
PlaceboDevice
Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) and given instructions. 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. The study will be double blinded as to the active vs placebo groups.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Product | Placebo comparator | Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups. Receives: Device: Placebo |
| Incrediwear Product | Active comparator | Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups. Receives: Device: Leg Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
Measured: 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)
Range of Motion Measured by a Goniometer
Knee flexion and extension to assess mobility and functionality of the knee joint. The knee joint's range of motion (ROM) is an important clinical parameter used in knee assessment. Knee flexion should be about 150 degrees and knee extension should be about zero degrees (American Medical Association). Lower degrees of flexion are not ideal while higher degrees of extension are not optimal.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start29 Oct 2024
- Primary completion29 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Prospective Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Bone and Joint
- Sponsor type
- University, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC., Medical City Denton
- Responsible party
- Principal investigator, Christopher Flowers, MD, Texas Bone and Joint
- Investigators
- Christopher Flowers, MD, MS, Principal investigator, Texas Bone and Joint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668376
- Sponsor's protocol ID
- IRBNet 2205451-2
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Pre-approval to share data and data results must be obtained by the corporation.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT06668376
- Acronym / sponsor ID
- IRBNet 2205451-2
- Keywords
- Anterior Cruciate Ligament Tear, Medial Collateral Ligament Tear, Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Arthroscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Texas Bone and JointUniversity, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC., Medical City Denton
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 31 Oct 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.
To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of motion and effusion. The study team will compare patients with Incrediwear products, or placebo Incrediwear products, or no products during the first 6-month postoperative period. The group that does not wear the Incrediwear or placebo products is considered the standard of care control group and will proceed with the normal standard of care compression hose.
Detailed description
After knee surgery, the participant will be randomly assigned to one of the three groups. The participant will have a 1-in-3 chance of being assigned to each group. The products will be placed on the participant by the hospital staff according to the random assignment sent with the surgical packet.
Study Screening/pre-operative appointment
- The surgeon confirms the participant meets the inclusion criteria and are scheduled for surgery in the next few weeks, and how the participant may be eligible to participate in the study.
- The surgeon will discuss the study and possible risks/benefits of being in the research.
- Day of surgery
- The study packet will be sent to the hospital by the clinical staff. The packet will include a study number assignment, the products assigned the study number, and the patient study journal. The participant, surgeon, and hospital staff will not know which group the participant are in, with the exception of the standard of care control group, as this group will wear the hospital-issued compression hose.
- Postoperative Recovery
- Subjective: Patient rates surgical site pain, on a 0-10 VAS pain scale. Patients will record pain medication type and quantity taken in a daily pain diary.
- Objective: Surgical extremity range of motion, and surgical extremity knee effusion, measured by either the Physical Therapist or the surgeon at the postop appointment.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Randomized Prospective Study
| Arm | Type | Receives |
|---|---|---|
| Placebo Product | Placebo comparator | Device: PlaceboOnce the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups. |
| Incrediwear Product | Active comparator | Device: Leg SleeveOnce the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups. |
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 protocol
- BMI less than 35
- Undergoing ACL or ACL+MCL within 30 days
Key exclusion criteria (9 listed)
- Pregnancy
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
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 |
|---|---|---|
| Leg SleeveOnce the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) and given instructions. 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. The study will be double blinded as to the active vs placebo groups. | Device | Incrediwear Product |
| PlaceboOnce the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) and given instructions. 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. The study will be double blinded as to the active vs placebo groups. | Device | Placebo Product |
Primary outcome
Visual Analogue Scale
Time frame: 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)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
Range of Motion Measured by a Goniometer
Time frame: 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)
Knee flexion and extension to assess mobility and functionality of the knee joint. The knee joint's range of motion (ROM) is an important clinical parameter used in knee assessment. Knee flexion should be about 150 degrees and knee extension should be about zero degrees (American Medical Association). Lower degrees of flexion are not ideal while higher degrees of extension are not optimal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Leg SleeveLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Pre-approval to share data and data results must be obtained by the corporation.
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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. This study is not recruiting at the moment.
Christopher Flowers, MD, MS principal investigator
Texas Bone and Joint
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Sleeve in people with Anterior Cruciate Ligament Tear and Medial Collateral Ligament, run by Texas Bone and Joint 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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?
Results are not available in the source record.
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?
Visual Analogue Scale (time frame: 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)). The study lists 2 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 1 Nov 2024.