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

Pseudarthrosis Clinical Trial

— TRUFFLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098157
• Other study ID #: TRUFFLE
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2023
• Source: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
• Contact: Marie K Reumann, MD
• Phone: +497071606
• Email: mreumann[@]bgu-tuebingen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Pseudarthrosis

Locations

Country	Name	City	State
Germany	Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	minimum of 1 year up to 5 years after non-union index procedure
Primary	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).	minimum of 1 year up to 5 years after non-union index procedure
Secondary	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.	minimum of 1 year up to 5 years after non-union index procedure
Secondary	number of medication	any intake of medication at time of non-union index procedure is listed. The number of medications are evaluated.	minimum of 1 year up to 5 years after non-union index procedure
Secondary	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	minimum of 1 year up to 5 years after non-union index procedure
Secondary	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).	minimum of 1 year up to 5 years after non-union index procedure
Secondary	NUSS - non union scoring system	All individual parameters of the 3 categories within the NUSS (bone-, patient- soft tissue related) are captured. A maximum score of 100 points can be scored. The score is related to 4 risk groups according to the number of points reached. The higher the number the points the higher is the risk group (1 - 25 points for risk group 1, 26 - 50 points for risk group 2, 51 - 75 points for risk group 3, 76 - 100 points for risk group 4). A surgical procedure is suggested according to the risk group with only limited surgical intervention in risk group 1 and increasing invasiveness for risk groups with higher scores (2, 3 and 4). Risk group 4 with the highest score level suggest severe surgical interventions (i.e. amputation or total joint implantation).; The NUSS and subsequent risk group - levels are analyzed at time of non-union index procedure and any subsequent follow up visit that requires a surgical procedure.	minimum of 1 year up to 5 years after non-union index procedure
Secondary	Weber Cech classification	Weber Cech classification (atrophic, hypertrophic, oligotrophic) at time of non-union index procedure	minimum of 1 year up to 5 years after non-union index procedure
Secondary	patient reported outcome measures (PROMS)	The EQ5D5L, a standardized measure of health-related quality of life developed by the EuroQol Group with 5 dimensions and 5 levels, is assessed by the patient at time of non-union index procedure and every follow- up visit. A score from 1 to 5 can be reached with 1 being the lowest, and 5 being the highest score. The higher the score the worse is the health state of the participant.	minimum of 1 year up to 5 years after non-union index procedure
Secondary	ASA (American Society of Anesthesiologists) classification	The ASA Score (I - VI) measures the physical status of a patients before surgical intervention.; ASA I represents a good state of health, while ASA VI represents a very severe state of health (i.e. a declared brain dead person). It is assessed at time of non-union index procedure and before any subsequent follow- up surgery.	minimum of 1 year up to 5 years after non-union index procedure