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

Not Applicable

Withdrawn

• Conditions: Scaphoid Fixation
• Interventions: Other: Early Active Controlled Motion (EACM)

• Registration Number: NCT03996512
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-08-01
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post scaphoid fracture with screw fixation	Early Active Controlled Motion (EACM)	Post surgical rehabilitation using an early active controlled wrist motion rehab protocol that limits the amount of proximal carpal row loading forces

Primary Outcome Measures

Name	Time	Method
functional outcome range of motion	at entry and up to 12 months	Using a goniometer measuring the angle of wrist flexion and extension; NEED TO ENTER EXPECTED ROM ranges