Anterior Cruciate Ligament Reconstruction Clinical Trial
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. 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
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Consented to protocol - Compliant to protocol - BMI less than 35 - Undergoing ACL or ACL+MCL within 30 days Exclusion Criteria: - Rheumatoid Arthritis - Poorly controlled diabetes (HgA1c > 7.5) - Previous blood clots - BMI greater than 35 - Varicosities on operative leg - Pain management patient - Prior knee surgery to the operative / study knee - Worker's Comp patients - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Oklahoma Joint Reconstruction Institute | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma Joint Reconstruction Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 180 days | |
Primary | Pain Medication Usage | Patient will document pain medication type and quantity taken in a daily pain diary. | 180 days | |
Primary | 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. | 180 days | |
Primary | Range of Motion | The patient's range of motion captured at all time points during the postoperative period. | 180 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06280456 -
Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction
|
N/A | |
Active, not recruiting |
NCT02772770 -
Pediatric ACL: Understanding Treatment Options
|
||
Terminated |
NCT00300300 -
Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
|
Phase 4 | |
Completed |
NCT00775892 -
SeriACLâ„¢ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
|
Phase 1/Phase 2 | |
Completed |
NCT04504344 -
Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
|
Phase 1 | |
Recruiting |
NCT06327555 -
Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction
|
N/A | |
Recruiting |
NCT05968729 -
Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol
|
N/A | |
Not yet recruiting |
NCT05972876 -
Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
|
N/A | |
Withdrawn |
NCT03688477 -
Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation
|
N/A | |
Completed |
NCT02945553 -
Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
|
Phase 1/Phase 2 | |
Recruiting |
NCT01279759 -
Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction
|
N/A | |
Completed |
NCT00245271 -
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
|
Phase 3 | |
Recruiting |
NCT06131047 -
High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction
|
N/A | |
Recruiting |
NCT06430775 -
Exploring Prolonged AMR in ACL Reconstructed Patients
|
||
Recruiting |
NCT06206200 -
The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction
|
N/A | |
Not yet recruiting |
NCT06318039 -
Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction
|
N/A | |
Recruiting |
NCT03336060 -
Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function
|
N/A | |
Completed |
NCT03304561 -
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
|
N/A | |
Not yet recruiting |
NCT05619393 -
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
|
N/A | |
Completed |
NCT02604550 -
Anterior Cruciate Ligament Pain Study
|
Phase 4 |