A Study to Evaluate the Incrediwear Products Immediately After ACL Repair

NAEnrolling by invitationINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 29, 2024

Primary Completion Date

October 29, 2026

Study Completion Date

November 1, 2026

Conditions
Anterior Cruciate Ligament TearMedial Collateral Ligament
Interventions
DEVICE

Leg Sleeve

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.

DEVICE

Placebo

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.

Trial Locations (1)

76210

Medical City Denton, Denton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

INCREDIWEAR HOLDINGS, INC.

INDUSTRY

collaborator

Medical City Denton

UNKNOWN

lead

Texas Bone and Joint

OTHER

NCT06668376 - A Study to Evaluate the Incrediwear Products Immediately After ACL Repair | Biotech Hunter | Biotech Hunter