Hallux RigidusNCT05795127
Risk for Reoperation After First MTP Joint Arthrodesis
An observational study of Hallux Rigidus and Orthopedic Disorder, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hallux Rigidus, Orthopedic Disorder, Surgery
- What is being tested?
- First metatarsophalangeal joint arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 1,213 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2022to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Child, Adult, Older adult
Study population: All patients treated in Helsinki University Hospital in 2010-2022
Who may be able to join
- First MTPJ arthrodesis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hallux Rigidus, Orthopedic Disorder, Surgery, Complication of Surgical Procedure, Hallux Valgus
- Being tested
- First metatarsophalangeal joint arthrodesis
- Keywords
- metatarsal, Hallux rigidus, Hallux valgus
- Medical subject headings
- Hallux Rigidus, Musculoskeletal Diseases, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First metatarsophalangeal joint arthrodesisProcedure or surgery
Surgery leadin to bony uninon in firts metatarsophalangeal joint
| Study group | Role | What they receive |
|---|---|---|
| Reoperated | Primary arthrodesis operations later requiring reoperation. Receives: Procedure: First metatarsophalangeal joint arthrodesis | |
| Control | Primary arthrodesis operations with no further operations. Size of the control group is four fold. Receives: Procedure: First metatarsophalangeal joint arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reoperations
Any OR located reoperation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies 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
- Retrospective
- Enrolment
- 1,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikko Miettinen, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795127
- Sponsor's protocol ID
- HUS/206/2022
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Reoperation After First MTP Joint Arthrodesis
- ClinicalTrials.gov ID
- NCT05795127
- Acronym / sponsor ID
- HUS/206/2022
- Conditions
- Hallux Rigidus, Orthopedic Disorder, Surgery, Complication of Surgical Procedure, Hallux Valgus
- Keywords
- metatarsal, Hallux rigidus, Hallux valgus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,213 participants (actual)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Apr 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reoperated | – | Procedure: First metatarsophalangeal joint arthrodesisPrimary arthrodesis operations later requiring reoperation. |
| Control | – | Procedure: First metatarsophalangeal joint arthrodesisPrimary arthrodesis operations with no further operations. Size of the control group is four fold. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated in Helsinki University Hospital in 2010-2022
Key inclusion criteria (1 listed)
- First MTPJ arthrodesis
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| First metatarsophalangeal joint arthrodesisSurgery leadin to bony uninon in firts metatarsophalangeal joint | Procedure or surgery | Control, Reoperated |
Primary outcome
Rate of reoperations
Time frame: 2 years
Any OR located reoperation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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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 Hallux Rigidus and Orthopedic Disorder, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Feb 2024. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of reoperations (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2024.