WithdrawnNot Applicable

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

Stopped: Recruitment issues. Inclusion Criteria was strict due to the experimental nature of intervention

0Started 2019-08-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

functional outcome range of motion

Timeframe: at entry and up to 12 months

Trial details

NCT IDNCT03996512

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-19