PseudarthrosisTRUFFLENCT06098157
Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
An observational study of Pseudarthrosis and Ununited Fracture, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudarthrosis, Ununited Fracture
- How many people
- 850 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for delayed bone healing or non-union in a level 1 hospital of maximum trauma care
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Marie K Reumann, MD, 7071606 ext. 3113, mreumann@bgu-tuebingen.de
About this study
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.
Read the 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.
- Conditions
- Pseudarthrosis, Ununited Fracture
- Keywords
- bone, non-union, delayed union, delayed bone healing, pseudarthrosis, callus formation, ununited fracture, fracture healing
- Medical subject headings
- Pseudarthrosis, Fractures, Ununited
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minimum of 1 year up to 5 years after non-union index procedure
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).
Measured: minimum of 1 year up to 5 years after non-union index procedure
Secondary outcomes (8)
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.
Measured: minimum of 1 year up to 5 years after non-union index procedure
number of medication
any intake of medication at time of non-union index procedure is listed. The number of medications are evaluated.
Measured: minimum of 1 year up to 5 years after non-union index procedure
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
Measured: minimum of 1 year up to 5 years after 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).
Measured: minimum of 1 year up to 5 years after non-union index procedure
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.
Measured: minimum of 1 year up to 5 years after non-union index procedure
Weber Cech classification
Weber Cech classification (atrophic, hypertrophic, oligotrophic) at time of non-union index procedure
Measured: minimum of 1 year up to 5 years after non-union index procedure
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.
Measured: minimum of 1 year up to 5 years after non-union index procedure
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.
Measured: minimum of 1 year up to 5 years after non-union index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 850 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie K. Reumann, Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
- Investigators
- Marie K Reumann, MD, Study director, Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098157
- Sponsor's protocol ID
- TRUFFLE
- Acronym
- TRUFFLE
- Status last verified
- Nov 2024
- First submitted
- 28 Sep 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
- ClinicalTrials.gov ID
- NCT06098157
- Acronym / sponsor ID
- TRUFFLE / TRUFFLE
- Conditions
- Pseudarthrosis, Ununited Fracture
- Keywords
- bone, non-union, delayed union, delayed bone healing, pseudarthrosis, callus formation, ununited fracture, fracture healing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik TuUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for delayed bone healing or non-union in a level 1 hospital of maximum trauma care
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of participants with successful bone healing
Time frame: minimum of 1 year up to 5 years after non-union index procedure
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 frame: minimum of 1 year up to 5 years after non-union index procedure
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).
8 secondary outcomes
Charlson Comorbidity Index
Time frame: minimum of 1 year up to 5 years after non-union index procedure
number of medication
Time frame: minimum of 1 year up to 5 years after non-union index procedure
number of participants undergoing type of revision surgery
Time frame: minimum of 1 year up to 5 years after non-union index procedure
number of participants suffering from local infection
Time frame: minimum of 1 year up to 5 years after non-union index procedure
NUSS - non union scoring system
Time frame: minimum of 1 year up to 5 years after non-union index procedure
Weber Cech classification
Time frame: minimum of 1 year up to 5 years after non-union index procedure
patient reported outcome measures (PROMS)
Time frame: minimum of 1 year up to 5 years after non-union index procedure
ASA (American Society of Anesthesiologists) classification
Time frame: minimum of 1 year up to 5 years after non-union index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie K Reumann, MD study director
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudarthrosis and Ununited Fracture, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie K Reumann, MD (+497071606 ext. 3113, mreumann@bgu-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with successful bone healing (time frame: minimum of 1 year up to 5 years after non-union index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.