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Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study

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ClinicalTrials.gov Identifier: NCT03996512
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Performance Health
Information provided by (Responsible Party):
University of Florida

Brief Summary:
There is poor research supporting the benefits of Early Active Controlled Motion (EACM) protocols post operative scaphoid fixation. Advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. The study uses a pre-experimental design with purposeful sample population recruitment.

Condition or disease Intervention/treatment Phase
Scaphoid Fixation Other: Early Active Controlled Motion (EACM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Post scaphoid fracture with screw fixation
Post surgical rehabilitation using an early active controlled wrist motion rehab protocol that limits the amount of proximal carpal row loading forces
Other: Early Active Controlled Motion (EACM)
Early active controlled wrist motion rehab protocol using that will allow midcarpal row motion.




Primary Outcome Measures :
  1. functional outcome range of motion [ Time Frame: at entry and up to 12 months ]

    Using a goniometer measuring the angle of wrist flexion and extension

    NEED TO ENTER EXPECTED ROM ranges




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Date of injury and diagnosis: scaphoid fracture less than 3 weeks old
  • Waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone.
  • Surgical procedure includes ORIF with screw fixation and/or percutaneous pin with screw fixation.
  • To be included in the study the patient needs to have started rehab within the first 10 days after surgery date.

Exclusion Criteria:

  • Proximal pole scaphoid fracture
  • Past medical history of diabetes and other peripheral vascular disorders.
  • History of osteopenia and osteoporosis.
  • Previously failed ORIF of scaphoid
  • Neurovascular or nerve lesion to the involved upper extremity
  • Cognitive deficits related to memory, attention span, judgment as documented in the EMR or need for a legal guardian to be a medical proxy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996512


Contacts
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Contact: Kelsey Hayes 904-244-3154 kelsey.hayes@jax.ufl.edu

Locations
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United States, Florida
University of Florida Not yet recruiting
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Performance Health
Investigators
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Principal Investigator: Sarah Mersch University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03996512     History of Changes
Other Study ID Numbers: IRB201900006
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No