Knee Split Comparison After ACL Reconstruction
Primary Purpose
ACL Tear, Arthrofibrosis, ACL Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Graymont X ERIS Knee Splint
Standard Hinge Knee Brace
Sponsored by
About this trial
This is an interventional treatment trial for ACL Tear
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Graymont X ERIS Knee Splint Degree Splinting Group
Standard Hinged Knee Brace
Arm Description
These patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol.
These patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol.
Outcomes
Primary Outcome Measures
Time to full symmetric extension
Time-to-achievement of full symmetric extension relative to the non-surgical knee
Range of motion
Includes heel-height measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT04360928
First Posted
March 6, 2020
Last Updated
July 27, 2023
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04360928
Brief Title
Knee Split Comparison After ACL Reconstruction
Official Title
Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tear, Arthrofibrosis, ACL Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graymont X ERIS Knee Splint Degree Splinting Group
Arm Type
Experimental
Arm Description
These patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol.
Arm Title
Standard Hinged Knee Brace
Arm Type
Sham Comparator
Arm Description
These patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol.
Intervention Type
Device
Intervention Name(s)
Graymont X ERIS Knee Splint
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Hinge Knee Brace
Intervention Description
Standard knee brace used postoperatively after ACL reconstruction.
Primary Outcome Measure Information:
Title
Time to full symmetric extension
Description
Time-to-achievement of full symmetric extension relative to the non-surgical knee
Time Frame
Up to 6 months postoperatively
Title
Range of motion
Description
Includes heel-height measurements
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD to other researchers.
Learn more about this trial
Knee Split Comparison After ACL Reconstruction
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