Pseudarthrosis Clinical Trial
— TRUFFLEOfficial title:
Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
NCT number | NCT06098157 |
Other study ID # | TRUFFLE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | December 31, 2030 |
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.
Status | Recruiting |
Enrollment | 850 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | |
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). |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen | Tübingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu |
Germany,
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 |
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