Amputation, SurgicalDEVSYMENCT06448260
Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
An observational study of Amputation, Surgical and Walking, Difficulty, run by Institut Robert Merle d'aubigné at 1 site in France.
Trial summary
The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation, Surgical, Walking, Difficulty
- What is being tested?
- Questionnary
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2024to 30 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient treated at the institut Rober Merle d'Aubigné
Who may be able to join
- 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
Who cannot join
- Refusal documented in the file that the data be used for scientific purposes,
- Congenital etiology of the condition.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.
- Conditions
- Amputation, Surgical, Walking, Difficulty
- Being tested
- Questionnary
- Keywords
- Amputation, Prothesis, Outcome
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with ATCT | Patient with tibiocalcaneal arthrodesis with talectomy amputation Receives: Other: Questionnary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The possibility of walking without a prosthesis
Yes / No
Measured: Immediatly after inclusion
Walking perimeter with prosthesis
In meters
Measured: Immediatly after inclusion
Number of re-amputation since first amputation
Measured: Immediatly after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 May 2024
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Amputation, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Institut Robert Merle d'aubigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448260
- Sponsor's protocol ID
- 2024-A00393-44
- Acronym
- DEVSYME
- Status last verified
- Oct 2024
- First submitted
- 1 Jun 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29320640Dillon 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.
PubMed 28288686van 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.
PubMed 36897730Spoden 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.
PubMed 30612550
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
- ClinicalTrials.gov ID
- NCT06448260
- Acronym / sponsor ID
- DEVSYME / 2024-A00393-44
- Conditions
- Amputation, Surgical, Walking, Difficulty
- Keywords
- Amputation, Prothesis, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut Robert Merle d'aubignéUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with ATCT | – | Other: QuestionnaryPatient with tibiocalcaneal arthrodesis with talectomy amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient treated at the institut Rober Merle d'Aubigné
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal documented in the file that the data be used for scientific purposes,
- Congenital etiology of the condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaryData 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. | Other | Patient with ATCT |
Primary outcome
The possibility of walking without a prosthesis
Time frame: Immediatly after inclusion
Yes / No
Walking perimeter with prosthesis
Time frame: Immediatly after inclusion
In meters
Number of re-amputation since first amputation
Time frame: Immediatly after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 29320640Braaksma 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.
- Background: PubMed 28288686Dillon 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.
- Background: PubMed 36897730van 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.
- Background: PubMed 30612550Spoden 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Surgical and Walking, Difficulty, run by Institut Robert Merle d'aubigné at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The possibility of walking without a prosthesis (time frame: Immediatly after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448260, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.