Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)NCT03170687
Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
A study testing short foot cast and short leg cast in people with Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II), run by Jatupon Kongtharvonskul at 1 site in Thailand.
Trial summary
This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
- What is being tested?
- short foot cast and short leg cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 24 Jan 2017to 1 Sep 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- more than 1 week
- comminuted or multiple fracture
- Open fracture
- Ligament and tendon injury
- Previous injury complication: nonunion, delayed union
- Malignancy
- refuse to inform consent
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).
Read the detailed description
A randomized controlled trial will conducts between January 2017 and January 2019, participants with acute fifth metatarsal fracture (Zone II) will recruit for this study at the orthopedic outpatient clinic of a police general hospital, Bangkok, Thailand. A total of 100 patients will randomly allocate to receive foot cast or short leg cast. acute closed fracture of proximal fifth metatarsal (zone II) patients.
- Being tested
- short foot cast, short leg cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short foot castDevice
metatarsal foot cast
short leg castDevice
full short leg cast
| Study group | Role | What they receive |
|---|---|---|
| foot cast | Experimental | Not described Receives: Device: short foot cast |
| short leg cast | Active comparator | Not described Receives: Device: short leg cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
visual analog score
Measured: 8 weeks
Secondary outcomes (3)
AOFAS
foot score
Measured: 8 weeks
union rate
radiographic union
Measured: 8 weeks
complication
skin ulcer or compartment syndrome
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start24 Jan 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jatupon Kongtharvonskul
- Sponsor type
- University, hospital or other
- Collaborators
- Police General Hospital
- Responsible party
- Sponsor-investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170687
- Sponsor's protocol ID
- 53/2560
- Status last verified
- Sep 2018
- First submitted
- 25 May 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)
- ClinicalTrials.gov ID
- NCT03170687
- Acronym / sponsor ID
- 53/2560
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jatupon KongtharvonskulUniversity, hospital or other
- Collaborators
- Police General Hospital
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 May 2017 (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.
This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).
Detailed description
A randomized controlled trial will conducts between January 2017 and January 2019, participants with acute fifth metatarsal fracture (Zone II) will recruit for this study at the orthopedic outpatient clinic of a police general hospital, Bangkok, Thailand. A total of 100 patients will randomly allocate to receive foot cast or short leg cast. acute closed fracture of proximal fifth metatarsal (zone II) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foot cast | Experimental | Device: short foot cast |
| short leg cast | Active comparator | Device: short leg cast |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- more than 1 week
- comminuted or multiple fracture
- Open fracture
- Ligament and tendon injury
- Previous injury complication: nonunion, delayed union
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 |
|---|---|---|
| short foot castmetatarsal foot cast | Device | foot cast |
| short leg castfull short leg cast | Device | short leg cast |
Primary outcome
VAS
Time frame: 8 weeks
visual analog score
3 secondary outcomes
AOFAS
Time frame: 8 weeks
union rate
Time frame: 8 weeks
complication
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short foot cast and short leg cast in people with Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II), run by Jatupon Kongtharvonskul at 1 site in Thailand.
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 0 inclusion and 7 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: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS (time frame: 8 weeks). 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 18 Sep 2018.