Fracture of Fifth Metatarsal BoneNCT04037540
Comparison of Conservative and Operative Treatment of Jones Fracture
A study testing Operational approach and Conservative approach in people with Fracture of Fifth Metatarsal Bone, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fracture of Fifth Metatarsal Bone
- What is being tested?
- Operational approach and Conservative approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2006to 31 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Jones fracture
Who cannot join
- combined injury
- recurring injury
- diabetes mellitus
- chronic renal insufficiency
- osteopathy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.
Read the detailed description
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.
The study proposes a supposition of recommending the active operational approach, which shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of the extremity for 8-12 weeks.
- Conditions
- Fracture of Fifth Metatarsal Bone
- Being tested
- Operational approach, Conservative approach
- Keywords
- Jones fracture, The American Orthopaedic Foot & Ankle Society (AOFAS), Herbert screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operational approachProcedure or surgery
Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.
Conservative approachProcedure or surgery
Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.
| Study group | Role | What they receive |
|---|---|---|
| Operational approach | Experimental | The patients enrolled in this arm underwent surgical treatment of the Jones fracture. Receives: Procedure: Operational approach |
| Conservative approach | Experimental | The patients enrolled in this arm were treated conservatively, using fixation of the injured extremity. Receives: Procedure: Conservative approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks
The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 6 weeks after injury on a scale of 0-100.
Measured: 6 weeks
AOFAS score - 12 months
The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 12 months after injury on a scale of 0-100.
Measured: 12 months
Secondary outcomes (3)
Signs of healing on X-ray at 6 weeks
The presence or absence of signs of healing on X-ray were observed at 6 weeks after injury.
Measured: 6 weeks
Signs of healing on X-ray at 12 months
The presence or absence of signs of healing on X-ray were observed at 12 months after injury.
Measured: 6 weeks
Extremity loading
The ability to load the injured extremity was measured in per cent of full loading.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Jan 2006
- Primary completion31 Dec 2011
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Fracture of Fifth Metatarsal BoneStudies 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
- Model description
- The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiří Demel, MD, Principal investigator, University Hospital OstravaLeopold Pleva, Ass.Prof.,MD,CSc., Study director, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037540
- Sponsor's protocol ID
- FNO-KUCH-01-Jones
- Other IDs
- CZ.02.1.01/00/00/17_049/00084
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers do not plan to share individual participant data with other researchers.
Publications
Dameron TB Jr. Fractures and anatomical variations of the proximal portion of the fifth metatarsal. J Bone Joint Surg Am. 1975 Sep;57(6):788-92.
PubMed 1099103Kavanaugh JH, Brower TD, Mann RV. The Jones fracture revisited. J Bone Joint Surg Am. 1978 Sep;60(6):776-82.
PubMed 701310Landorf KB. Clarifying proximal diaphyseal fifth metatarsal fractures. The acute fracture versus the stress fracture. J Am Podiatr Med Assoc. 1999 Aug;89(8):398-404. doi: 10.7547/87507315-89-8-398.
PubMed 10466292Malkus T, Soukup B. [Jones fracture.]. Acta Chir Orthop Traumatol Cech. 1999;66(1):15-21. Czech.
PubMed 20478127Marshall PD, Evans PD, Richards J. Laboratory comparison of the cannulated Herbert bone screw with ASIF cancellous lag screws. J Bone Joint Surg Br. 1993 Jan;75(1):89-92. doi: 10.1302/0301-620X.75B1.8421045.
PubMed 8421045Mindrebo N, Shelbourne KD, Van Meter CD, Rettig AC. Outpatient percutaneous screw fixation of the acute Jones fracture. Am J Sports Med. 1993 Sep-Oct;21(5):720-3. doi: 10.1177/036354659302100514.
PubMed 8238714Nunley JA. Fractures of the base of the fifth metatarsal: the Jones fracture. Orthop Clin North Am. 2001 Jan;32(1):171-80. doi: 10.1016/s0030-5898(05)70200-5.
PubMed 11465126Pietropaoli MP, Wnorowski DC, Werner FW, Fortino MD. Intramedullary screw fixation of Jones fractures: a biomechanical study. Foot Ankle Int. 1999 Sep;20(9):560-3. doi: 10.1177/107110079902000904.
PubMed 10509682Quill GE Jr. Fractures of the proximal fifth metatarsal. Orthop Clin North Am. 1995 Apr;26(2):353-61.
PubMed 7724197Rosenberg GA, Sferra JJ. Treatment strategies for acute fractures and nonunions of the proximal fifth metatarsal. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):332-8. doi: 10.5435/00124635-200009000-00007.
PubMed 11029561STEWART IM. Jones's fracture: fracture of base of fifth metatarsal. Clin Orthop. 1960;16:190-8. No abstract available.
PubMed 13834594
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative and Operative Treatment of Jones Fracture
- ClinicalTrials.gov ID
- NCT04037540
- Acronym / sponsor ID
- FNO-KUCH-01-Jones
- Conditions
- Fracture of Fifth Metatarsal Bone
- Keywords
- Jones fracture, The American Orthopaedic Foot & Ankle Society (AOFAS), Herbert screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Jul 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.
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.
Detailed description
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.
The study proposes a supposition of recommending the active operational approach, which shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of the extremity for 8-12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.
| Arm | Type | Receives |
|---|---|---|
| Operational approach | Experimental | Procedure: Operational approachThe patients enrolled in this arm underwent surgical treatment of the Jones fracture. |
| Conservative approach | Experimental | Procedure: Conservative approachThe patients enrolled in this arm were treated conservatively, using fixation of the injured extremity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Jones fracture
Key exclusion criteria (5 listed)
- combined injury
- recurring injury
- diabetes mellitus
- chronic renal insufficiency
- osteopathy
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 |
|---|---|---|
| Operational approachOperational approach was used to treat the Jones fracture in patients randomized into the respective study arm. | Procedure or surgery | Operational approach |
| Conservative approachConservative approach was used to treat the Jones fracture in patients randomized into the respective study arm. | Procedure or surgery | Conservative approach |
Primary outcome
The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks
Time frame: 6 weeks
The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 6 weeks after injury on a scale of 0-100.
AOFAS score - 12 months
Time frame: 12 months
The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 12 months after injury on a scale of 0-100.
3 secondary outcomes
Signs of healing on X-ray at 6 weeks
Time frame: 6 weeks
Signs of healing on X-ray at 12 months
Time frame: 6 weeks
Extremity loading
Time frame: 6 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 31 Jul 2019.
- Background: PubMed 1099103Dameron TB Jr. Fractures and anatomical variations of the proximal portion of the fifth metatarsal. J Bone Joint Surg Am. 1975 Sep;57(6):788-92.
- Background: PubMed 701310Kavanaugh JH, Brower TD, Mann RV. The Jones fracture revisited. J Bone Joint Surg Am. 1978 Sep;60(6):776-82.
- Background: PubMed 10466292Landorf KB. Clarifying proximal diaphyseal fifth metatarsal fractures. The acute fracture versus the stress fracture. J Am Podiatr Med Assoc. 1999 Aug;89(8):398-404. doi: 10.7547/87507315-89-8-398.
- Background: PubMed 20478127Malkus T, Soukup B. [Jones fracture.]. Acta Chir Orthop Traumatol Cech. 1999;66(1):15-21. Czech.
- Background: PubMed 8421045Marshall PD, Evans PD, Richards J. Laboratory comparison of the cannulated Herbert bone screw with ASIF cancellous lag screws. J Bone Joint Surg Br. 1993 Jan;75(1):89-92. doi: 10.1302/0301-620X.75B1.8421045.
- Background: PubMed 8238714Mindrebo N, Shelbourne KD, Van Meter CD, Rettig AC. Outpatient percutaneous screw fixation of the acute Jones fracture. Am J Sports Med. 1993 Sep-Oct;21(5):720-3. doi: 10.1177/036354659302100514.
- Background: PubMed 11465126Nunley JA. Fractures of the base of the fifth metatarsal: the Jones fracture. Orthop Clin North Am. 2001 Jan;32(1):171-80. doi: 10.1016/s0030-5898(05)70200-5.
- Background: PubMed 10509682Pietropaoli MP, Wnorowski DC, Werner FW, Fortino MD. Intramedullary screw fixation of Jones fractures: a biomechanical study. Foot Ankle Int. 1999 Sep;20(9):560-3. doi: 10.1177/107110079902000904.
- Background: PubMed 7724197Quill GE Jr. Fractures of the proximal fifth metatarsal. Orthop Clin North Am. 1995 Apr;26(2):353-61.
- Background: PubMed 11029561Rosenberg GA, Sferra JJ. Treatment strategies for acute fractures and nonunions of the proximal fifth metatarsal. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):332-8. doi: 10.5435/00124635-200009000-00007.
- Background: PubMed 13834594STEWART IM. Jones's fracture: fracture of base of fifth metatarsal. Clin Orthop. 1960;16:190-8. No abstract available.
- Individual participant dataSharing planned: No. The researchers do not plan to share individual participant data with other researchers.
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.
Jiří Demel, MD principal investigator
University Hospital Ostrava
Leopold Pleva, Ass.Prof.,MD,CSc. study director
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operational approach and Conservative approach in people with Fracture of Fifth Metatarsal Bone, run by University Hospital Ostrava at 1 site in Czechia.
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 1 inclusion and 5 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 31 Jul 2019. 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 Czechia. 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?
The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037540, which also lists 11 linked publications.
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 31 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.