About this trial
TRUFFLE is a register of clinical patient data of failed bone healing and bone non-union after fracture. All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases. The aim is to identify risk factors for healing of non-unions. Data analysis will compare those patients that undergo regular healing to those of insufficient healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age >18 years
presence of long bone non-union that required surgical treatment.
radiological signs according to the criteria of the Radiographic Union Scale of Tibial fractures (RUST).
clinical signs as pain, lack of weight bearing and/or limitation on range of motion.
Disqualifiers
age <18 years
Patients with non surgical intervention and presence of long bone non-union
bone non-union that resulted from elective orthopedic surgery (e.g. osteotomies).
Trial population
Patients treated for delayed bone healing or non-union in a level 1 hospital of maximum trauma care
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
number of participants with successful bone healing
End of treatment can either be successful healing or treatment with no success in bone healing (i.e. amputation, total joint replacement). The number of participants reaching successful healing (responders) to those who are not reaching successful healing (non-responders) will be analyzed.
Time to heal
Time to heal is defined as the length of time from non-union index procedure to date of last follow-up visit that stated radiographic and clinical success or unsuccessful bone healing (i.e. amputation, total joint replacement).
Secondary outcomes
Charlson Comorbidity Index
Comorbidities are listed according to the Charlson Comorbidity Index, at time of non-union index procedure. 19 comorbidities and patients age are listed according to which a score from 0 to \> 5 is calculated. A 1 - year mortality risk is predicted. The higher the score from 0 to 5 combined with increasing age, the higher the risk of mortality, with 0 as the lowest score with the lowest risk, and \> 5 as the highest score with the highest risk.
number of medication
any intake of medication at time of non-union index procedure is listed. The number of medications are evaluated.
number of participants undergoing type of revision surgery
number of participants undergoing several types of revision surgery (plate, nail, external fixation, autologous bone grafting) at time of non-union index procedure
number of participants suffering from local infection
number of participants suffering from type of local infection at time of non-union index procedure is listed. Microbiological tests can reveal bacterial infection. Any sort of bacterial infection of local soft tissue and bone non-union according to microbiological tests are listed and qualify for infection (yes or no).
Sponsors and contacts
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