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

NCT ID: NCT06098157

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Pseudarthrosis Ununited Fracture

Keywords

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bone non-union delayed union delayed bone healing pseudarthrosis callus formation ununited fracture fracture healing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Marie K. Reumann

Principal Investigator, Head of Clinical Trauma Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie K Reumann, MD

Role: STUDY_DIRECTOR

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Locations

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Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marie K Reumann, MD

Role: CONTACT

Phone: +497071606

Email: [email protected]

Facility Contacts

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Marie K Reumann, MD

Role: primary

Other Identifiers

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TRUFFLE

Identifier Type: -

Identifier Source: org_study_id