Risk for Reoperation After First MTP Joint Arthrodesis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Complication of Surgical Procedure; Orthopedic Disorder; Hallux Valgus; Hallux Rigidus
• Intervention / Treatment: Procedure: First metatarsophalangeal joint arthrodesis

Detailed Description

The number of primary surgery in the adult population (age 18 years or older) will be collected from patient information systems using the NOMESCO procedure code NHG80 regardless of diagnosis. These patients will be further screened for diabetes and arthritic diseases (the International Classification of Diseases 10th Revision (ICD-10) diagnostic codes E10.**-E14.** and M05.**-M14.**). As reoperations will be considered surgery under the NOMESCO procedure codes NH***, QDB***, QDG***, ZZH***. Comorbidities were collected from the previous patient health records by diagnosis codes for diabetes type 1 (E10.**), other diabetes (E11.**-14.**), seropositive rheumatoid arthritis (M05.9), seronegative rheumatoid arthritis (M06.0), psoriasis (M07.**), gout (M10.**), other arthritis (M09.**, M11-M14).

The data will be divided and analyzed in two separate phases. First we will gather all the information that we can reliably utilize from the register. The data will include the primary operation, all reoperations, experience level of the surgeon, patients' age, sex, and whether the patient has been diagnosed with other comorbidities stated above.

In the second phase, we will collect matched patients for the patients who underwent reoperations using propensity score matching with ratio of 1:3 with nearest neighbour method. The variables used for matching will be age, sex and all other comorbidities (diabetes type 1, other diabetes, seropositive rheumatoid arthritis, seronegative rheumatoid arthritis, psoriasis, gout, other arthritis) We will further screen the medical records of the reoperated patients as well the matched controls. From pre- and post-operative x-rays we will determine the degree of arthrosis and hallux valgus and intermetatarsal angles. Operation reports will be screened for surgical technique (i.e. method of cartilage removal, fixation and use of bone transport). These data will be used to analyze the association of perioperative factors and reoperations. These models will not be including variables that were used in matching.

During the both phases, we will use logistic regression to analyze association between assumed risk factors and reoperations by using the data from the register (first phase) or from the patients' health records and x-rays (second phase). We will evaluate causality with directed acyclic graphs (DAG), and develop logistic models separately for each of the assumed risk factors. The variables used in the DAGs will be selected based on previous knowledge and hypothesized causal relationships. Results from both analyses will interpreted with adjusted odds ratios (OR) with 95 % confidence intervals (CI). Model fit will be assessed by McFadden R2 -index, multicollinearity by evaluating Variance Inflation Factor (VIF) and heteroscedasticity by inspecting the fitted values vs. residual plots. Statistical analyses will be performed with R version 4.0.5.

• Study Type: Observational
• Enrollment (Actual): 1213

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029 HUS
    • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients treated in Helsinki University Hospital in 2010-2022

Description

Inclusion Criteria:

First MTPJ arthrodesis

Exclusion Criteria:

none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reoperated; Primary arthrodesis operations later requiring reoperation.	Procedure: First metatarsophalangeal joint arthrodesis; Surgery leadin to bony uninon in firts metatarsophalangeal joint
Control; Primary arthrodesis operations with no further operations. Size of the control group is four fold.	Procedure: First metatarsophalangeal joint arthrodesis; Surgery leadin to bony uninon in firts metatarsophalangeal joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of reoperations	Any OR located reoperation	2 years

Collaborators and Investigators

• Sponsor: Hospital District of Helsinki and Uusimaa

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hallux valgus; metatarsal; Hallux rigidus
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Musculoskeletal Diseases; Hallux Valgus; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: HUS/206/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No