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Dynamic ACL Brace: In Vivo Kinematics

Primary Purpose

ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ossur Rebound ACL Brace
Sponsored by
Steadman Philippon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ACL Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury, significant meniscal damage
  • Allergy or sensitivity to silver or latex
  • Adults lacking capacity to consent for themselves

Post-Op Visit Exclusion Criteria

  • 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.

Sites / Locations

  • Steadman Philippon Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knee Brace

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percent symmetry in 3D motion capture kinematics and kinetics
Whole-body kinematics and ground reaction forces will be calculated to assess joint angle and ground reaction force symmetry between braced and unbraced conditions during activities of daily living (<1wk) and dynamic/sports activities(7-9months post-operatively).
Muscle contribution levels in braced vs unbraced knee
Electromyography sensors will detect differences in muscle contributions (in major muscles of the lower extremity) between the braced ipsilateral leg, unbraced ipsilateral leg, and contralateral leg during activities of daily living and dynamic sports activities.
Subject Satisfaction
An overall satisfaction score for brace comfort will be obtained from the 'Quebec User Evaluation of Satisfaction with Assistive Technology.'

Full Information

First Posted
September 6, 2018
Last Updated
February 12, 2019
Sponsor
Steadman Philippon Research Institute
Collaborators
Össur Ehf
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1. Study Identification

Unique Protocol Identification Number
NCT03670550
Brief Title
Dynamic ACL Brace: In Vivo Kinematics
Official Title
Dynamic ACL Brace: In Vivo Kinematics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Attending surgeon on the project is moving to a different facility
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steadman Philippon Research Institute
Collaborators
Össur Ehf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL, ACL - Anterior Cruciate Ligament Deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evaluation of knee stability with brace wear. Control is same subject without the brace.
Masking
None (Open Label)
Masking Description
Investigators and participants cannot be blinded as to whether or not the brace is worn.
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee Brace
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ossur Rebound ACL Brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees
Description
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.
Time Frame
<1wk (pre-operative)
Title
Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees
Description
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.
Time Frame
7-9 months (post-operative)
Secondary Outcome Measure Information:
Title
Percent symmetry in 3D motion capture kinematics and kinetics
Description
Whole-body kinematics and ground reaction forces will be calculated to assess joint angle and ground reaction force symmetry between braced and unbraced conditions during activities of daily living (<1wk) and dynamic/sports activities(7-9months post-operatively).
Time Frame
<1wk; 7-9months
Title
Muscle contribution levels in braced vs unbraced knee
Description
Electromyography sensors will detect differences in muscle contributions (in major muscles of the lower extremity) between the braced ipsilateral leg, unbraced ipsilateral leg, and contralateral leg during activities of daily living and dynamic sports activities.
Time Frame
<1wk; 7-9 months
Title
Subject Satisfaction
Description
An overall satisfaction score for brace comfort will be obtained from the 'Quebec User Evaluation of Satisfaction with Assistive Technology.'
Time Frame
2 months; 4 months; 7-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury, significant meniscal damage Allergy or sensitivity to silver or latex Adults lacking capacity to consent for themselves Post-Op Visit Exclusion Criteria 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.
Facility Information:
Facility Name
Steadman Philippon Research Institute
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7358757
Citation
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.
Results Reference
background
PubMed Identifier
24497504
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
2782535
Citation
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.
Results Reference
background
PubMed Identifier
23624655
Citation
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.
Results Reference
background
PubMed Identifier
23807029
Citation
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.
Results Reference
background
PubMed Identifier
28748195
Citation
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.
Results Reference
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Dynamic ACL Brace: In Vivo Kinematics

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