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Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial

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Ce qui est testé

Graymont X ERIS Knee Splint

+ Standard Hinge Knee Brace

Dispositif médical
Qui peut participer

Blessures du ligament croisé antérieur+1

+ Blessures du genou

+ Blessures de la jambe

De 18 à 40 ans
+13 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Groupe Placebo
Interventionnel
Date de début : août 2023
Voir le détail du protocole

Résumé

Sponsor principalRush University Medical Center
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 août 2023

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielPostoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
NCT04360928
Sponsor principalRush University Medical Center
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

21 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 40 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Blessures du ligament croisé antérieurBlessures du genouBlessures de la jambeBlessures et lésions

Critères

4 critères d'inclusion nécessaires pour participer
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 critères d'exclusion empêchent la participation
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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

50% de chances d'être dans le groupe placebo en aveugle

Groupes de traitement

Groupe I

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

Groupe II

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

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

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Rush University Medical Center

Chicago, United StatesOuvrir Rush University Medical Center dans Google Maps
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