Knee Split Comparison After ACL Reconstruction

NCT04360928 | Terminated

• 1 other identifier: 20030401
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ACL Tear; Arthrofibrosis; ACL Injury

Outcome Measures

Primary Outcomes (2)

• Time to full symmetric extension

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

  Up to 6 months postoperatively

• Range of motion

  Includes heel-height measurements

  6 months postoperatively

Study Arms (2)

Graymont X ERIS Knee Splint Degree Splinting Group

EXPERIMENTAL

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

Device: Graymont X ERIS Knee Splint

Standard Hinged Knee Brace

SHAM COMPARATOR

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

Device: Standard Hinge Knee Brace

Interventions

Graymont X ERIS Knee Splint DEVICE

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.

Graymont X ERIS Knee Splint Degree Splinting Group

Standard Hinge Knee Brace DEVICE

Standard knee brace used postoperatively after ACL reconstruction.

Standard Hinged Knee Brace

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary ACL Reconstruction
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: April 24, 2020
• Study Start: August 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 6, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)