Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-10-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Knee Brace
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.
Ossur Rebound ACL Brace
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.
Interventions
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Ossur Rebound ACL Brace
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Össur Iceland ehf
INDUSTRY
Steadman Philippon Research Institute
OTHER
Responsible Party
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Locations
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Steadman Philippon Research Institute
Vail, Colorado, United States
Countries
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References
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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.
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.
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
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.
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.
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.
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.
Other Identifiers
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2018-31
Identifier Type: -
Identifier Source: org_study_id
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