Dynamic ACL Brace: In Vivo Kinematics

NCT03670550 | Withdrawn FDA Device

• 1 other identifier: 2018-31
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of the Össur Rebound dynamic ACL brace on knee kinematics evaluated using dynamic stereo X-ray (DSX) imaging during functional activities. Brace performance will be evaluated before and after ACL reconstruction.

Conditions

ACL Injury; ACL - Anterior Cruciate Ligament Rupture; ACL; ACL - Anterior Cruciate Ligament Deficiency

Outcome Measures

Primary Outcomes (2)

• Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees

  This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during walking and stair-climbing, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-deficient knee, unbraced ACL-deficient knee, and the contralateral/uninjured knee.

  <1wk (pre-operative)

• Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees

  This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during dynamic movements and sports activities, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-reconstructed knee, unbraced ACL-reconstructed knee, and contralateral/uninjured knee.

  7-9 months (post-operative)

Secondary Outcomes (3)

• Percent symmetry in 3D motion capture kinematics and kinetics

  <1wk; 7-9months

• Muscle contribution levels in braced vs unbraced knee

  <1wk; 7-9 months

• Subject Satisfaction

  2 months; 4 months; 7-9 months

Study Arms (1)

Knee Brace

EXPERIMENTAL

ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy. Dynamic X-ray imaging of the knee will take place prior to surgery, and again upon clearance from physical therapy 7-9 months after surgery. The injured knee will be imaged with and without the brace, and the contralateral limb will be imaged for use as a control.

Device: Ossur Rebound ACL Brace

Interventions

Ossur Rebound ACL Brace DEVICE

ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy. The intervention (brace) will be applied only to the surgical limb.

Knee Brace

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral, complete ACL (Anterior Cruciate Ligament) ruptures (must be documented by prior MRI)
• No other concomitant lower extremity injuries and an uninjured contralateral limb
• Acute ACL tears that will be scheduled for ACL reconstruction with Dr. Robert F. LaPrade
• Minimal swelling and pain
• Able and willing to perform the required study activities

You may not qualify if:

• Previous surgery or significant injury to either knee
• Relevant surgery, procedure, injury, or condition in the past two years which may affect knee pain or general movement patterns on either side
• Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health
• Women who are pregnant, or trying/planning to become pregnant during the next 10 months
• Known balance or vestibular disorders
• Persons with a history of significant radiation exposure, whether occupational or medical in nature (Anyone with a history of medical radiation therapy, for cancer or other conditions, is excluded from the study. Those who have an annual occupational radiation exposure greater than 25mSv may not enroll.)
• Persons with a pacemaker, hearing aid, aneurysm clip or artificial heart valve, or other forms of loose metal implants
• Allergy or sensitivity to silver or latex
• Adults lacking capacity to consent for themselves
• Participants who do not pass their return-to-sport test within 7-9 months of ACL-Reconstruction surgery will be excluded from the second phase of testing.
• Participants who no longer pass the MRI screening at the time of Phase 2 testing (for example, who have a new loose metal implant), will be excluded from the MRI portion of the testing only.

Sponsors & Collaborators

• Steadman Philippon Research Institute: lead
• Össur Iceland ehf: collaborator

Study Sites (1)

Steadman Philippon Research Institute

Vail, Colorado, 81657, United States

Location

Related Publications (7)

• Butler DL, Noyes FR, Grood ES. Ligamentous restraints to anterior-posterior drawer in the human knee. A biomechanical study. J Bone Joint Surg Am. 1980 Mar;62(2):259-70. No abstract available.

  PMID: 7358757 BACKGROUND

• Kiapour AM, Murray MM. Basic science of anterior cruciate ligament injury and repair. Bone Joint Res. 2014 Feb 4;3(2):20-31. doi: 10.1302/2046-3758.32.2000241. Print 2014.

  PMID: 24497504 BACKGROUND

• Marshall, T., Gelber, J., & Spindler, K. (2016). Postoperative Knee Bracing After Anterior Cruciate Ligament Reconstruction. Operative Techniques in Sports Medicine, 24(1), 55-58. DOI: 10.1053/j.otsm.2015.10.001

  BACKGROUND

• Cook FF, Tibone JE, Redfern FC. A dynamic analysis of a functional brace for anterior cruciate ligament insufficiency. Am J Sports Med. 1989 Jul-Aug;17(4):519-24. doi: 10.1177/036354658901700412.

  PMID: 2782535 BACKGROUND

• Smith SD, Laprade RF, Jansson KS, Aroen A, Wijdicks CA. Functional bracing of ACL injuries: current state and future directions. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1131-41. doi: 10.1007/s00167-013-2514-z. Epub 2013 Apr 27.

  PMID: 23624655 BACKGROUND

• Mayr HO, Stueken P, Munch EO, Wolter M, Bernstein A, Suedkamp NP, Stoehr A. Brace or no-brace after ACL graft? Four-year results of a prospective clinical trial. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1156-62. doi: 10.1007/s00167-013-2564-2. Epub 2013 Jun 27.

  PMID: 23807029 BACKGROUND

• LaPrade RF, Venderley MB, Dahl KD, Dornan GJ, Turnbull TL. Functional Brace in ACL Surgery: Force Quantification in an In Vivo Study. Orthop J Sports Med. 2017 Jul 6;5(7):2325967117714242. doi: 10.1177/2325967117714242. eCollection 2017 Jul.

  PMID: 28748195 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigators and participants cannot be blinded as to whether or not the brace is worn.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of knee stability with brace wear. Control is same subject without the brace.

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 13, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)