Status:
TERMINATED
Knee Split Comparison After ACL Reconstruction
Lead Sponsor:
Rush University Medical Center
Conditions:
ACL Tear
Arthrofibrosis
Eligibility:
All Genders
18-40 years
Phase:
NA
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 ex...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04360928
Start Date
August 1 2023
End Date
January 6 2025
Last Update
January 9 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612