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Knee Split Comparison After ACL Reconstruction

NCT04360928 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-01-09

No results posted yet for this study

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

Interventions

DEVICE

Graymont X ERIS Knee Splint

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.

DEVICE

Standard Hinge Knee Brace

Standard knee brace used postoperatively after ACL reconstruction.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-01-01
Completion
2025-01-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360928 on ClinicalTrials.gov