Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDepartment of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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 frame
minimum of 1 year up to 5 years after non-union index procedure
2

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).

Time frame
minimum of 1 year up to 5 years after non-union index procedure

Secondary outcomes

1

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.

Time frame
minimum of 1 year up to 5 years after non-union index procedure
2

number of medication

any intake of medication at time of non-union index procedure is listed. The number of medications are evaluated.

Time frame
minimum of 1 year up to 5 years after non-union index procedure
3

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

Time frame
minimum of 1 year up to 5 years after non-union index procedure
4

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).

Time frame
minimum of 1 year up to 5 years after non-union index procedure

Other outcomes

Sponsors and contacts

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