Clinical trial NCT03670550: Dynamic ACL Brace: In Vivo Kinematics
Official title: Dynamic ACL Brace: In Vivo Kinematics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ACL Injury
ACL - Anterior Cruciate Ligament Rupture
ACL
ACL - Anterior Cruciate Ligament Deficiency
Lead sponsor: Steadman Philippon Research Institute
Sponsor class: OTHER
Collaborators: name: Össur Iceland ehf
First posted: 2018-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of knee stability with brace wear. Control is same subject without the brace.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees
timeFrame: <1wk (pre-operative)
measure: Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees
timeFrame: 7-9 months (post-operative)
Secondary outcomes:
measure: Percent symmetry in 3D motion capture kinematics and kinetics
timeFrame: <1wk; 7-9months
measure: Muscle contribution levels in braced vs unbraced knee
timeFrame: <1wk; 7-9 months
measure: Subject Satisfaction
timeFrame: 2 months; 4 months; 7-9 months
Other outcomes:
Locations:
city: Vail
country: United States
facility: Steadman Philippon Research Institute
state: Colorado
Study officials:
References:
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.
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.
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
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.
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.
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.
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.