An observational study in Fracture Non Union, Fracture Healing and Long Bone Delayed-Union Fracture, sponsored by Charite University, Berlin, Germany. Recruiting at 7 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Charite University, Berlin, Germany · Observational
In approx. 10-15% of all fracture patients, there is a prolonged healing time or even a complete absence of fracture healing (non-union). As a result, these patients require further surgical interventions, combined with renewed or prolonged hospitalisation/rehabilitation and incapacity to work. To summarise, this therefore represents a serious socio-economic problem. At present, there is no prognostic method for the early prediction of patients at risk of a disturbed healing process. However, if these patients are successfully stratified, there are already a variety of therapeutic strategies available to additionally stimulate fracture healing. Therefore, the aim is to conduct a prospective clinical study to validate CD8+ TEMRA cells as a prognostic marker of impaired fracture healing. The investigators assume that preoperative CD8+ TEMRA cell expression represents a prognostic biomarker with high diagnostic precision for differentiating between a) normal healing patients, b) delayed healing patients and c) pseudarthrosis patients. Furthermore, the sensitivity and specificity should be high enough, health-economically significant and realisable in clinical routine.
The aim is to identify high-risk patients before the initial operation based on their immunological profile and to be able to provide them with an improved, individualised therapeutic strategy. There are already a large number of approved therapeutic options that are currently only used in revision cases because, among other things, preoperative diagnostics and prognostics are lacking. Furthermore, a sufficient preoperatively determined biomarker would form the basis for the development of new therapeutic approaches, which represent a low cost-benefit and risk-benefit ratio.
The prospective biomarker validation study is applied in a routine-adapted procedure, i.e. all visits are part of the clinical radiological and functional routine checks. Blood sampling on arrival at the hospital will be used to determine the preoperative value of CD8+TEMRA cells. The healing process will be recorded using X-ray/CT images, radiological scores and functional clinical examinations as well as the SF-36. The 1st study endpoint (delayed healing) is after 17-19 weeks postoperatively, the 2nd study endpoint (pseudarthrosis) after 34-36 weeks. The validation of the biomarker will take place in a blinded procedure, whereby the predefined threshold value of the preoperative CD8+ TEMRA cell expression will be compared with the patient's healing status.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 640 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
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University Hospital UniversityCentre for Orthopaedics and Trauma Surgery Dresden Charité Universitätsmedizin Berlin Centre for Musculoskeletal Surgery Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg Clinic Trauma Hospital Berlin Berlin Vivantes Hospital Spandau Berlin Clinic University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig
Exclusion Criteria:
Humerus fracture, forearm fracture, femoral fracture. tibia fracture
Diagnostic Test: CD8+TEMRA
Clinical assessement of the fracture consolidation at first study endpoint based on radiological images
Clinical assessement of the fracture consolidation (yes/no) based on radiological images at primary end point
Time frame: From surgery to 19 weeks post surgery
clinical assessement of the fracture consolidation at second study endpoint based on radiological images
fracture consolidation (yes/no) after 36 weeks post surgery based on radiological images.
Time frame: From surgery to 36 weeks post surgery
Ability to work
Period of return to work in days
Time frame: From surgery to 1 year post surgery
Proportion of subjects with an additional intervention independent of a surgical or non-surgical treatment to foster the fracture healing process
Number of surgically invasive and non-invasive measures
Time frame: From surgery to 1 year post surgery
Duration of Physiotherapy
Duration of physiotherapy sessions (units) done with a professional post-surgery.
Time frame: From surgery to 1 year post surgery
Weight bearing and fracture healing
Time to complete full weight bearing post surgery (weeks).
Time frame: From surgery to 1 year post surgery
Rehabilitation and fracture healing
Proportion of subjects with inpatient or day-care rehabilitation post surgery.
Time frame: From surgery to 1 year post surgery
Infection rate
Proportion of subjects with postoperative infections
Time frame: From surgery to 1 year post surgery
Plan to share: No — For data protection reasons, no individual participant data will be shared
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Charite University, Berlin, Germany