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ACL InjuryNCT03670550

Dynamic ACL Brace: In Vivo Kinematics

A study testing Ossur Rebound ACL Brace in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Steadman Philippon Research Institute at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Ossur Rebound ACL Brace
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Steadman Philippon Research Institute

    Vail, Colorado, 81657

Other trials in United States

About this study

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.

Being tested
Ossur Rebound ACL Brace
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ossur Rebound ACL BraceDevice

    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.

Study groups in NCT03670550
Study groupRoleWhat they receive
Knee BraceExperimentalACL-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.
Receives: Device: Ossur Rebound ACL Brace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: <1wk (pre-operative)

  2. 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.

    Measured: 7-9 months (post-operative)

Secondary outcomes (3)

  1. 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).

    Measured: <1wk; 7-9months

  2. 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.

    Measured: <1wk; 7-9 months

  3. Subject Satisfaction

    An overall satisfaction score for brace comfort will be obtained from the 'Quebec User Evaluation of Satisfaction with Assistive Technology.'

    Measured: 2 months; 4 months; 7-9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completionApr 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Why it stopped: Attending surgeon on the project is moving to a different facility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Evaluation of knee stability with brace wear. Control is same subject without the brace.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670550
Sponsor's protocol ID
2018-31
Status last verified
Apr 2026
First submitted
6 Sep 2018
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 7358757

  • 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.

    PubMed 24497504

  • 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.

    PubMed 2782535

  • 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.

    PubMed 23624655

  • 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.

    PubMed 23807029

  • 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.

    PubMed 28748195

Questions about this trial

What is this clinical trial studying?

A study testing Ossur Rebound ACL Brace in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Steadman Philippon Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees (time frame: <1wk (pre-operative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670550, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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