Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04360928 |
| Other study ID # |
20030401 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
January 1, 2026 |
Study information
| Verified date |
July 2023 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
