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

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.

Study Overview

• Status: Withdrawn
• Conditions: Scaphoid Fixation
• Intervention / Treatment: Other: Early Active Controlled Motion (EACM)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Performance Health
• Investigators: Principal Investigator: Sarah Mersch, University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): January 19, 2021
• Study Completion (ACTUAL): January 19, 2021

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IRB201900006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No