Knee Split Comparison After ACL Reconstruction

ACL Injury Clinical Trial

Official title: Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial

Status Not yet recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ACL Injury
• ACL Tear
• Anterior Cruciate Ligament Injuries
• Arthrofibrosis

• NCT number: NCT04360928
• Study type: Interventional
• Source: Rush University Medical Center
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: January 1, 2026