Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05795127 |
| Other study ID # |
HUS/206/2022 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
January 1, 2028 |
Study information
| Verified date |
February 2024 |
| Source |
Hospital District of Helsinki and Uusimaa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
