Clinical trial NCT06098157: Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
Official title: Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudarthrosis
Ununited Fracture
Keywords: bone
non-union
delayed union
delayed bone healing
pseudarthrosis
callus formation
ununited fracture
fracture healing
Lead sponsor: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for delayed bone healing or non-union in a level 1 hospital of maximum trauma care

Brief summary: 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.

Detailed description: Bone non-union is a severe complication in trauma surgery. It requires complex surgical intervention leading to decisive restrictions for the patient as well as socioeconomic burden for the health care systems. Despite extensive research, up to date, bone healing has not yet been fully understood. Many risk factors impairing bone healing causing delayed healing or even non-union after fracture have been studied in the past. However, these studies mainly focus on secondary and tertiary prevention measures id est when fracture healing is delayed or the non-union is already present. Research concerning the identification of risk factors concerning primary prevention of non-healing after non-union treatment are scarce, usually investigate a certain anatomical location. Also, as the incidence of non-union (5 % to 10 %) is very low, these studies often only include a limited number of cases and brief follow-up periods.

Thus, TRUFFLE was started as a register for non-union cases aiming for large number of patients cases with consisted data and a follow-up period till the end of treatment.

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.

All parameters examined are evaluated at the time of non-union index procedure. Data include demographic parameters as age and gender, type of primary injury according to classification of the AO foundation, severity of primary injury (injury severity score (ISS) \> 16), Gustilo-Anderson classification at the time of initial trauma, presence of traumatic brain injury, number of previous soft tissue surgeries before non-union index procedure. The state of infection of the designated bone segment stated by proof of microbiological colonization at the time of non-union index procedure is assessed, as well as Weber/Cech classification of non-union. Comorbidities such as diabetes mellitus, cardiovascular disease, rheumatological conditions, cancer and neurological disease (i.e. Parkinson's disease), as well as tobacco smoking and classification according to the American Society of Anesthesiologists (ASA classification) are assessed. Intake of medication and lab parameters are listed. Any subsequent revision surgery related to the designated non-union is included during patients follow-up. The NUSS- Score is evaluated and calculated according to above listed parameters. Also, subjective parameters of patients quality of life are included at non-union index procedure and at subsequent follow-ups.

Bone healing or unsuccessful healing serve as primary outcome parameter as well as time to heal.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: number of participants with successful bone healing
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: Time to heal
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
Secondary outcomes:
measure: Charlson Comorbidity Index
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: number of medication
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: number of participants undergoing type of revision surgery
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: number of participants suffering from local infection
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: NUSS - non union scoring system
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: Weber Cech classification
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: patient reported outcome measures (PROMS)
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
measure: ASA (American Society of Anesthesiologists) classification
timeFrame: minimum of 1 year up to 5 years after non-union index procedure
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
name: Marie K Reumann, MD
role: STUDY_DIRECTOR
References: