NCT04037540

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2011

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

6 years

First QC Date

July 26, 2019

Last Update Submit

July 30, 2019

Conditions

Keywords

Jones fractureThe American Orthopaedic Foot & Ankle Society (AOFAS)Herbert screw

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 months

Secondary Outcomes (3)

  • Signs of healing on X-ray at 6 weeks

    6 weeks

  • Signs of healing on X-ray at 12 months

    6 weeks

  • Extremity loading

    6 weeks

Study Arms (2)

Operational approach

EXPERIMENTAL

The patients enrolled in this arm underwent surgical treatment of the Jones fracture.

Procedure: Operational approach

Conservative approach

EXPERIMENTAL

The patients enrolled in this arm were treated conservatively, using fixation of the injured extremity.

Procedure: Conservative approach

Interventions

Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.

Operational approach

Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.

Conservative approach

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Jones fracture

You may not qualify if:

  • combined injury
  • recurring injury
  • diabetes mellitus
  • chronic renal insufficiency
  • osteopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (11)

  • 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.

    PMID: 1099103BACKGROUND
  • Kavanaugh JH, Brower TD, Mann RV. The Jones fracture revisited. J Bone Joint Surg Am. 1978 Sep;60(6):776-82.

    PMID: 701310BACKGROUND
  • Landorf 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.

    PMID: 10466292BACKGROUND
  • Malkus T, Soukup B. [Jones fracture.]. Acta Chir Orthop Traumatol Cech. 1999;66(1):15-21. Czech.

    PMID: 20478127BACKGROUND
  • Marshall 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.

    PMID: 8421045BACKGROUND
  • Mindrebo 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.

    PMID: 8238714BACKGROUND
  • Nunley 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.

    PMID: 11465126BACKGROUND
  • Pietropaoli 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.

    PMID: 10509682BACKGROUND
  • Quill GE Jr. Fractures of the proximal fifth metatarsal. Orthop Clin North Am. 1995 Apr;26(2):353-61.

    PMID: 7724197BACKGROUND
  • Rosenberg 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.

    PMID: 11029561BACKGROUND
  • STEWART IM. Jones's fracture: fracture of base of fifth metatarsal. Clin Orthop. 1960;16:190-8. No abstract available.

    PMID: 13834594BACKGROUND

Study Officials

  • Jiří Demel, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR
  • Leopold Pleva, Ass.Prof.,MD,CSc.

    University Hospital Ostrava

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was used in the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

January 1, 2006

Primary Completion

December 31, 2011

Study Completion

December 31, 2018

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

The researchers do not plan to share individual participant data with other researchers.

Locations