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ACL TearNCT04360928

Knee Split Comparison After ACL Reconstruction

A study testing Graymont X ERIS Knee Splint and Standard Hinge Knee Brace in people with ACL Tear and Arthrofibrosis, run by Rush University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
ACL Tear, Arthrofibrosis, ACL Injury
What is being tested?
Graymont X ERIS Knee Splint and Standard Hinge Knee Brace
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 6 Jan 2025
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Patients lacking decisional capacity
  • Pregnant or breast-feeding women
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  • Worker's compensation patients
  • Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
  • Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial

This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. This will be directly measured with goniometric angle and heel-height measurements relative to the contralateral side. Other metrics will include standard, validated patient reported outcomes and requirements for additional interventions to treat extension deficits including, but not limited to, additional therapy, intraarticular injections, oral corticosteroids, manipulation under anesthesia, or arthroscopic arthrolysis.

Read the detailed description

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.

Being tested
Graymont X ERIS Knee Splint, Standard Hinge Knee Brace
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.

  • Graymont X ERIS Knee SplintDevice

    Specific type of splint which utilizes an inflatable air pocket on the posterior aspect of the leg to provide a combination of bracing and splinting in full extension in the immediate postoperative period.

  • Standard Hinge Knee BraceDevice

    Standard knee brace used postoperatively after ACL reconstruction.

Study groups in NCT04360928
Study groupRoleWhat they receive
Graymont X ERIS Knee Splint Degree Splinting GroupExperimentalThese patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol.
Receives: Device: Graymont X ERIS Knee Splint
Standard Hinged Knee BraceSham comparatorThese patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol.
Receives: Device: Standard Hinge Knee Brace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to full symmetric extension

    Time-to-achievement of full symmetric extension relative to the non-surgical knee

    Measured: Up to 6 months postoperatively

  2. Range of motion

    Includes heel-height measurements

    Measured: 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start1 Aug 2023
  3. Primary completion1 Jan 2025
  4. Study completion6 Jan 2025

Why it stopped: Recruitment goals not met

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360928
Sponsor's protocol ID
20030401
Status last verified
Jan 2025
First submitted
6 Mar 2020
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share IPD to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Graymont X ERIS Knee Splint and Standard Hinge Knee Brace in people with ACL Tear and Arthrofibrosis, run by Rush University Medical Center 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: stopped early, as of the sponsor's last update on 9 Jan 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?

The study was stopped early (reason given: Recruitment goals not met). 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?

Time to full symmetric extension (time frame: Up to 6 months postoperatively). 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 9 Jan 2025.

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