Phase None NCT04360928

Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial

Rush University Medical Center · Interventional, Randomized

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Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT04360928).

Recruitment criteria

Age range: 18–40 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase
Phase None
Study type
Interventional
Allocation
Randomized
Masking
Single-blind
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment target
— participants
Started
August 2023

Outcome measures

Locationsi

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Rush University Medical Center — Chicago, Illinois (United States)

Sources

REG
ClinicalTrials.gov — NCT04360928
Trial registry · primary record
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