Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
DEVSYME
1 other identifier
observational
94
1 country
1
Brief Summary
The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2024
CompletedFirst Submitted
Initial submission to the registry
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedApril 16, 2025
October 1, 2024
2 months
June 1, 2024
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The possibility of walking without a prosthesis
Yes / No
Immediatly after inclusion
Walking perimeter with prosthesis
In meters
Immediatly after inclusion
Number of re-amputation since first amputation
Immediatly after inclusion
Study Arms (1)
Patient with ATCT
Patient with tibiocalcaneal arthrodesis with talectomy amputation
Interventions
Data from theses patients will be collected in our personnal data base with ask of consent according to the law Then each patient alive will have questionnary to answer by phone or during a visit.
Eligibility Criteria
Patient treated at the institut Rober Merle d'Aubigné
You may qualify if:
- Syme or Pirogoff or ATCT or arthrodesized Chopart type amputation
- Age \> 18 years old,
- First fitting or renewal of Syme type prosthesis delivered to IRMA between January 2008 and December 2018
You may not qualify if:
- Refusal documented in the file that the data be used for scientific purposes,
- Congenital etiology of the condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Robert Merle d'Aubigné
Valenton, France
Related Publications (4)
Braaksma R, Dijkstra PU, Geertzen JHB. Syme Amputation: A Systematic Review. Foot Ankle Int. 2018 Mar;39(3):284-291. doi: 10.1177/1071100717745313. Epub 2018 Jan 10.
PMID: 29320640BACKGROUNDDillon MP, Quigley M, Fatone S. Outcomes of dysvascular partial foot amputation and how these compare to transtibial amputation: a systematic review for the development of shared decision-making resources. Syst Rev. 2017 Mar 14;6(1):54. doi: 10.1186/s13643-017-0433-7.
PMID: 28288686BACKGROUNDvan der Wal GE, Dijkstra PU, Geertzen JHB. Lisfranc and Chopart amputation: A systematic review. Medicine (Baltimore). 2023 Mar 10;102(10):e33188. doi: 10.1097/MD.0000000000033188.
PMID: 36897730BACKGROUNDSpoden M, Nimptsch U, Mansky T. Amputation rates of the lower limb by amputation level - observational study using German national hospital discharge data from 2005 to 2015. BMC Health Serv Res. 2019 Jan 6;19(1):8. doi: 10.1186/s12913-018-3759-5.
PMID: 30612550BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2024
First Posted
June 7, 2024
Study Start
May 20, 2024
Primary Completion
July 31, 2024
Study Completion
September 30, 2024
Last Updated
April 16, 2025
Record last verified: 2024-10