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Comparison of Conservative and Operative Treatment of Jones Fracture

Primary Purpose

Fracture of Fifth Metatarsal Bone

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Operational approach

Conservative approach

About this trial

This is an interventional treatment trial for Fracture of Fifth Metatarsal Bone focused on measuring Jones fracture, The American Orthopaedic Foot & Ankle Society (AOFAS), Herbert screw

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Jones fracture

Exclusion Criteria:

combined injury
recurring injury
diabetes mellitus
chronic renal insufficiency
osteopathy

Sites / Locations

University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Operational approach

Conservative approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Extremity loading

The ability to load the injured extremity was measured in per cent of full loading.

Full Information

NCT ID

NCT04037540

First Posted

July 26, 2019

Last Updated

July 30, 2019

Sponsor

University Hospital Ostrava

1. Study Identification

Unique Protocol Identification Number

NCT04037540

Brief Title

Comparison of Conservative and Operative Treatment of Jones Fracture

Official Title

Comparison of Conservative and Operative Treatment of Jones Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2006 (Actual)

Primary Completion Date

December 31, 2011 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fracture of Fifth Metatarsal Bone

Keywords

Jones fracture, The American Orthopaedic Foot & Ankle Society (AOFAS), Herbert screw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.

Masking

None (Open Label)

Masking Description

No masking was used in the study

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Operational approach

Arm Type

Experimental

Arm Description

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

Arm Title

Conservative approach

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Operational approach

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conservative approach

Intervention Description

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

Primary Outcome Measure Information:

Title

The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks

Description

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.

Time Frame

6 weeks

Title

AOFAS score - 12 months

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Signs of healing on X-ray at 6 weeks

Description

The presence or absence of signs of healing on X-ray were observed at 6 weeks after injury.

Time Frame

6 weeks

Title

Signs of healing on X-ray at 12 months

Description

The presence or absence of signs of healing on X-ray were observed at 12 months after injury.

Time Frame

6 weeks

Title

Extremity loading

Description

The ability to load the injured extremity was measured in per cent of full loading.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Jones fracture Exclusion Criteria: combined injury recurring injury diabetes mellitus chronic renal insufficiency osteopathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiří Demel, MD

Organizational Affiliation

University Hospital Ostrava

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leopold Pleva, Ass.Prof.,MD,CSc.

Organizational Affiliation

University Hospital Ostrava

Official's Role

Study Director

Facility Information:

Facility Name

University Hospital Ostrava

City

Ostrava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

70852

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

1099103

Citation

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.

Results Reference

background

PubMed Identifier

701310

Citation

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

Results Reference

background

PubMed Identifier

10466292

Citation

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.

Results Reference

background

PubMed Identifier

20478127

Citation

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

Results Reference

background

PubMed Identifier

8421045

Citation

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.

Results Reference

background

PubMed Identifier

8238714

Citation

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.

Results Reference

background

PubMed Identifier

11465126

Citation

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.

Results Reference

background

PubMed Identifier

10509682

Citation

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.

Results Reference

background

PubMed Identifier

7724197

Citation

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

Results Reference

background

PubMed Identifier

11029561

Citation

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.

Results Reference

background

PubMed Identifier

13834594

Citation

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

Results Reference

background

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Comparison of Conservative and Operative Treatment of Jones Fracture

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