The risk of infection from transcutaneous K-wire ends in proximal phalanx fractures

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024887

Enrollment

120

Registered

2021-03-26

Start date

2021-04-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S62.61

Interventions

Group 1: Group A: transcutaneous wire ends Group 2: Group A: subscutaneous wire ends

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Criteria for inclusion: ? Ability to understand the study-details and ability to sign the agreement ? Ability to agree on participating ? Age of consent ? Instable fracture of the proximal phlanx with indication for surgery ? completed growth and closed epiphyseal plates

Exclusion criteria

Exclusion criteria: Criteria for exclusion: ? Current participation in another ongoing study ? Stable fractures that should be treated conservatively ? Fractures that are too old for surgery ? Fractures which should be treated in another way than by K-wire osteosynthesis ? Complex injuries of the hand with damage to nerves, vessels and tendons ? Growth not yet completed and visible epiphyseal plates ? Any other diseases of the hands which compromise follow up checks

Design outcomes

Primary

Measure	Time frame
Most data will be analysed with a Bayesian A/B test. The A/B test compares two sample proportions and is therefore the standard operating procedure for the analysis of binary clinical trial data. Non-binary data will be analysed with a Bayesian t-test. We make use of the Bayesian approach for two reasons: First, because it allows us to monitor the evidence as the data accumulates. Second, because it allows us to obtain evidence in favour of the null hypothesis (i.e., that there is no difference between the two groups). We will analyse the data sequentially. The first analysis will be conducted after N = 20 patients (10 patients in group “A” and 10 patients in group “B”). This analysis will also be discussed in a monitoring board. We will then monitor the Bayes Factor and terminate the study whenever the Bayes Factor presents strong evidence; meaning that the Bayes Factor is either of 10 in favour of the null hypothesis or 10 in favour of the alternative hypothesis. Conducting the analysis this way allows us to provide an optimal treatment to as many patients as possible, because we can immediately stop the trial if there is strong evidence that one treatment method is superior. The study will also be stopped whenever we reach 120 patients (60 patients in each group). Further, the study will resume on the 1st of February 2024. We will examine the patients after 1, 3 and 6 weeks. These appointments are based on the typical, clinical check-up protocol. After 6 months, there will be another, study specific check-up. Regular check-ups Signs of infection -Tumor -Rubor -Dolor -Calor -Pus X-Ray Diagnostics -Dislocation of material -Consolidation after 6 weeks Skin irritation by wire ends Study specific check-up Subjective Outcome -PRWE -DASH-Score -MAYO-Wrist-Score -Score for pain and satisfaction TAM (total active motion) TPM (total passive motion) Strength of the hand Removing the metal by surgery -necessity -duration -time point Regular check-ups & Study spe	—

Measure

Time frame

Most data will be analysed with a Bayesian A/B test. The A/B test compares two sample proportions and is therefore the standard operating procedure for the analysis of binary clinical trial data. Non-binary data will be analysed with a Bayesian t-test. We make use of the Bayesian approach for two reasons: First, because it allows us to monitor the evidence as the data accumulates. Second, because it allows us to obtain evidence in favour of the null hypothesis (i.e., that there is no difference between the two groups). We will analyse the data sequentially. The first analysis will be conducted after N = 20 patients (10 patients in group “A” and 10 patients in group “B”). This analysis will also be discussed in a monitoring board. We will then monitor the Bayes Factor and terminate the study whenever the Bayes Factor presents strong evidence; meaning that the Bayes Factor is either of 10 in favour of the null hypothesis or 10 in favour of the alternative hypothesis. Conducting the analysis this way allows us to provide an optimal treatment to as many patients as possible, because we can immediately stop the trial if there is strong evidence that one treatment method is superior. The study will also be stopped whenever we reach 120 patients (60 patients in each group). Further, the study will resume on the 1st of February 2024. We will examine the patients after 1, 3 and 6 weeks. These appointments are based on the typical, clinical check-up protocol. After 6 months, there will be another, study specific check-up. Regular check-ups Signs of infection -Tumor -Rubor -Dolor -Calor -Pus X-Ray Diagnostics -Dislocation of material -Consolidation after 6 weeks Skin irritation by wire ends Study specific check-up Subjective Outcome -PRWE -DASH-Score -MAYO-Wrist-Score -Score for pain and satisfaction TAM (total active motion) TPM (total passive motion) Strength of the hand Removing the metal by surgery -necessity -duration -time point Regular check-ups & Study spe

—

Secondary

Measure	Time frame
Temporal limitation of the study on February 1, 2024	—

Countries

Germany

Contacts

Public ContactSebastian Hoffmann

BG Klinik Tübingen

shoffmann@bgu-tuebingen.de007071 606 1444

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026