NCT04937764

Brief Summary

Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate. Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 8, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2009

Completed
12.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

June 16, 2021

Last Update Submit

June 16, 2021

Conditions

Arthritis Foot

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement of the AOFAS score of the midfoot

    AOFAS Score

    1 year post surgery

Study Arms (1)

Study population

Population who underwent a surgical arthrodesis procedure for arthritic or inflammatory involvement of the Lisfranc tarsometatarsal joint

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in the department of orthopeadic surgery of the CHU NANCY

You may qualify if:

  • All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in
  • Age \> 18 ans

You may not qualify if:

  • Follow-up \< 6 months
  • Lost to follow-up
  • lack of data in the patient record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU NANCY, Central Hospital

Nancy, Meurthe Et Moselle, 54000, France

Location

Study Officials

  • Didier Mainard, Pr

    CHU NANCY

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

April 8, 2008

Primary Completion

January 27, 2009

Study Completion

October 30, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

No sharing data

Locations

FR(1)