NCT05795127

Brief Summary

We will screen all first metatarsophalangeal joint arthrodeses performed between 2010 and 2022 in Helsinki University Hospital. Information about demographics and additional diagnoses will be yielded from data pool of medical records. Additionally we review pre- and post-operative x-rays for first MTP joint angles and OR records for operative techniques. Our aim is to find associations between those known variables and risk for reoperation in two years after operation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,213

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress69%
Oct 2022Jan 2028

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

March 21, 2023

Last Update Submit

February 27, 2024

Conditions

Hallux RigidusOrthopedic DisorderSurgeryComplication of Surgical ProcedureHallux Valgus

Keywords

metatarsalHallux rigidusHallux valgus

Outcome Measures

Primary Outcomes (1)

  • Rate of reoperations

    Any OR located reoperation

    2 years

Study Arms (2)

Reoperated

Primary arthrodesis operations later requiring reoperation.

Procedure: First metatarsophalangeal joint arthrodesis

Control

Primary arthrodesis operations with no further operations. Size of the control group is four fold.

Procedure: First metatarsophalangeal joint arthrodesis

Interventions

First metatarsophalangeal joint arthrodesisPROCEDURE

Surgery leadin to bony uninon in firts metatarsophalangeal joint

ControlReoperated

Eligibility Criteria

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

All patients treated in Helsinki University Hospital in 2010-2022

You may qualify if:

  • First MTPJ arthrodesis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Location

MeSH Terms

Conditions

Hallux RigidusMusculoskeletal DiseasesHallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesJoint Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Principal Investigator

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

October 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)