Suspended

Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial

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What is being tested

Graymont X ERIS Knee Splint

+ Standard Hinge Knee Brace

Device
Who is being recruted

Anterior Cruciate Ligament Injuries+1

+ Knee Injuries

+ Leg Injuries

From 18 to 40 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2023
See protocol details

Summary

Principal SponsorRush University Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2023

Actual date on which the first participant was enrolled.

This study will be a prospective randomized controlled trial of patients undergoing arthroscopic reconstruction of full thickness ACL tears with bone-patellar tendon-bone autograft. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. Subjects will be appropriately fitted for the brace corresponding to randomization on the day of surgery. All braces will be placed on the subject in the operating room at the conclusion of the procedure. All patient will begin a standardized physical therapy protocol on postoperative day 1-14. Follow-up will take place at standard of care office visits at 1-week, 2-week, 6-weeks, 12-weeks, and 6-months. Range of motion, including goniometric angle and heel-height measurements, will be recorded at all postoperative time points. Time-to-achievement of full symmetric extension relative to the non-surgical knee will be monitored and recorded. At 3, 6, and 12 months, patients will also be asked to complete standardized, patient-reported outcomes questionnaires including IKDC, KOOS, PROMIS, VAS pain, VR/SF 12, and brief resilience scale. Patients will also be asked to answer questions regarding return to work and return to sport throughout the 1-year postoperative period. Both treatment groups will progress according to standardized, postoperative rehabilitation programs, similar to the program outlined below. Phase I: Protection, Range of Motion (ROM), and Proprioception Goal: • To protect the surgical graft, restore lower extremity mobility, and proprioception Precautions: * Patient can initiate immediate weight bearing with knee immobilizer brace locked at 0º extension. * Patients may unlock or remove brace once they are able to perform a straight leg raise without any quadriceps lag and perform a single leg stance (SLS) on surgical limb for at least 30 seconds. Patients must also wear the brace with any weight bearing activity for six weeks. Criteria for progression to next phase: * Non-antalgic gait with no observable gait impairments * ROM: Goal of extension to at least 0º, and flexion within 10º of contralateral knee. * Perform single leg stance on surgical limb on dynamic surfaces (balance board, foam, etc.) Exercises to be included: ROM: * Flexion: heel slides, wall slides, prone hamstring curls * Extension: supine or prone hangs, hamstring and calf stretching NWB strengthening: • Quadriceps sets (prone and supine), leg raises, and bridges on a swiss ball Proprioception: • SLS from static to dynamic surfaces and movements, 3-way lunges, balance board, rebounder or therapist ball tossing Phase II: Strength and Endurance Goal: • Build single limb endurance and to prepare for agility training Precautions: • No running/jogging or jumping. Criteria for progression to next phase: * Full, pain free knee AROM within 3º of contralateral knee * Able to perform single leg squat to approximately 60º knee flexion for 2 minutes without joint pain or compensations * No compensatory gait patterns during faster ambulation speeds Exercises to be included: ROM: • Stretching as needed (calf, hamstring, quad, trunk, upper body) NWB: • Trunk/core dynamics Proprioception: • Single leg stance with trunk rotations (use resistance for progression), floor touches, cone pick-ups on stable and unstable surfaces Phase III: Power and Agility Goal: • Gain type II, fast twitch muscle fibers and prepare for return to sport training Precautions: * Not to be initiated until at least 12 weeks post-operatively * No uncontrolled jumping (i.e. on grass, when not supervised by medical staff) * No cutting or pivoting at full speeds Criteria for progression to next phase: * Perform single leg squat to approximately 60º knee flexion for 3 minutes against external resistance * Perform lateral and diagonal jumping of a distance equal to the patient's leg length or greater for 2 minutes or longer * Perform double leg jumps from at least. a 12-inch surface * Perform single leg static jumps from flat surface Exercises to be included: Leg press, lunge, hamstring curl Agility: • Ladder training, cone drills, lateral and diagonal jumping adding external resistance Phase IV: Return to Sport Training Precautions: * No physical contact during sport specific training * No live sport performance until cleared by functional sports assessment and surgeon Patients will undergo standard of care physical therapy 2-3 times per week for 20 weeks as directed by their physician. Physical therapy will begin as directed by physician generally before post op day 14.

Official TitlePostoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
NCT04360928
Principal SponsorRush University Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anterior Cruciate Ligament InjuriesKnee InjuriesLeg InjuriesWounds and Injuries

Criteria

4 inclusion criteria required to participate
Primary ACL Reconstruction

No associated repair or reconstruction procedures (meniscal repair, other ligamentous pathology). Patients undergoing concurrent partial meniscectomy would be eligible for inclusion.

Clinical and radiographic examination (MRI), performed as standard of care prior to study enrollment, consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft

Written and informed consent for study participation

9 exclusion criteria prevent from participating
Patients younger than 18 or older than 40 years of age

Revision surgery or prior history of knee surgery

Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol

Inability to comply with the proposed follow-up clinic visits

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
These patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol.

Group II

Sham
These patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rush University Medical Center

Chicago, United StatesOpen Rush University Medical Center in Google Maps
SuspendedOne Study Center