Dynamic ACL Brace: In Vivo Kinematics

ACL Injury Clinical Trial

Official title:

Dynamic ACL Brace: In Vivo Kinematics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03670550
• Other study ID #: 2018-31
• Status: Withdrawn
• Phase: N/A
• Start date: October 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Steadman Philippon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL
• ACL - Anterior Cruciate Ligament Deficiency
• ACL - Anterior Cruciate Ligament Rupture
• ACL Injury
• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Steadman Philippon Research Institute	Vail	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Steadman Philippon Research Institute	Össur Ehf

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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

Mayr HO, Stüeken P, Münch 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. — View Citation

Smith SD, Laprade RF, Jansson KS, Arøen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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).	<1wk; 7-9months
Secondary	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.	<1wk; 7-9 months
Secondary	Subject Satisfaction	An overall satisfaction score for brace comfort will be obtained from the 'Quebec User Evaluation of Satisfaction with Assistive Technology.'	2 months; 4 months; 7-9 months