Scaphoid FixationNCT03996512
Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
A study of Scaphoid Fixation, run by University of Florida.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Scaphoid Fixation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 19 Jan 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this 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.
- Conditions
- Scaphoid Fixation
- Being tested
- Early Active Controlled Motion (EACM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Active Controlled Motion (EACM)Other
Early active controlled wrist motion rehab protocol using that will allow midcarpal row motion.
| Study group | Role | What they receive |
|---|---|---|
| Post scaphoid fracture with screw fixation | Experimental | Post surgical rehabilitation using an early active controlled wrist motion rehab protocol that limits the amount of proximal carpal row loading forces Receives: Other: Early Active Controlled Motion (EACM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome range of motion
Using a goniometer measuring the angle of wrist flexion and extension
NEED TO ENTER EXPECTED ROM ranges
Measured: at entry and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Aug 2019
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Why it stopped: Recruitment issues. Inclusion Criteria was strict due to the experimental nature of intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid FixationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Performance Health
- Responsible party
- Sponsor
- Investigators
- Sarah Mersch, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996512
- Sponsor's protocol ID
- IRB201900006
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2019
- Last updated
- 25 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
- ClinicalTrials.gov ID
- NCT03996512
- Acronym / sponsor ID
- IRB201900006
- Conditions
- Scaphoid Fixation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment issues. Inclusion Criteria was strict due to the experimental nature of intervention
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Performance Health
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post scaphoid fracture with screw fixation | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Active Controlled Motion (EACM)Early active controlled wrist motion rehab protocol using that will allow midcarpal row motion. | Other | Post scaphoid fracture with screw fixation |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Scaphoid Fixation
Recruiting
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Medial Malleolus Fracture, Lisfranc Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Mersch principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study of Scaphoid Fixation, run by University of Florida.
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 4 inclusion and 6 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
functional outcome range of motion (time frame: at entry and up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2021.