Comparison of Conservative and Operative Treatment of Jones Fracture
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|ClinicalTrials.gov Identifier: NCT04037540|
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fracture of Fifth Metatarsal Bone||Procedure: Operational approach Procedure: Conservative approach||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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|
|Official Title:||Comparison of Conservative and Operative Treatment of Jones Fracture|
|Actual Study Start Date :||January 1, 2006|
|Actual Primary Completion Date :||December 31, 2011|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Operational approach
The patients enrolled in this arm underwent surgical treatment of the Jones fracture.
Procedure: Operational approach
Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.
Experimental: Conservative approach
The patients enrolled in this arm were treated conservatively, using fixation of the injured extremity.
Procedure: Conservative approach
Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.
- 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.
- Signs of healing on X-ray at 6 weeks [ Time Frame: 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 [ Time Frame: 6 weeks ]The presence or absence of signs of healing on X-ray were observed at 12 months after injury.
- Extremity loading [ Time Frame: 6 weeks ]The ability to load the injured extremity was measured in per cent of full loading.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037540
|University Hospital Ostrava|
|Ostrava, Moravian-Silesian Region, Czechia, 70852|
|Principal Investigator:||Jiří Demel, MD||University Hospital Ostrava|
|Study Director:||Leopold Pleva, Ass.Prof.,MD,CSc.||University Hospital Ostrava|