Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities (NCT06098157) | Clinical Trial Compass
RecruitingNot Applicable
Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
Germany850 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of participants with successful bone healing
Timeframe: minimum of 1 year up to 5 years after non-union index procedure
2
Time to heal
Timeframe: minimum of 1 year up to 5 years after non-union index procedure
Trial details
NCT IDNCT06098157
SponsorDepartment of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu