NCT06448260

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

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

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

May 20, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 16, 2025

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

June 1, 2024

Last Update Submit

April 15, 2025

Conditions

Keywords

AmputationProthesisOutcome

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

Other: Questionnary

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.

Patient with ATCT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 29320640BACKGROUND
  • Dillon 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: 28288686BACKGROUND
  • van 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: 36897730BACKGROUND
  • Spoden 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

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

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

Locations