Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support

Walking, Difficulty Clinical Trial

— DEVSYME  

Official title:

Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448260
• Other study ID #: 2024-A00393-44
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Institut Robert Merle d'aubigné
• Contact: Anton M KANIEWSKI, MD
• Phone: +33609445348
• Email: a.kaniewski[@]irma-valenton.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refusal documented in the file that the data be used for scientific purposes,
• Congenital etiology of the condition.

Related Conditions & MeSH terms

• Mobility Limitation
• Walking, Difficulty

Intervention

Other:
• Questionnary
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.

Locations

Country	Name	City	State
France	Institut Robert Merle d'Aubigné	Valenton

Sponsors (1)

Lead Sponsor	Collaborator
Institut Robert Merle d'aubigné

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. Erratum In: BMC Health Serv Res. 2019 Mar 14;19(1):163. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The possibility of walking without a prosthesis	Yes / No	Immediatly after inclusion
Primary	Walking perimeter with prosthesis	In meters	Immediatly after inclusion
Primary	Number of re-amputation since first amputation		Immediatly after inclusion