Spinal (Fusion) Surgery
Conditions
Keywords
osteoanabolic treatment, parathyroid hormone (PTH), bone healing disorder
Brief summary
This study is to review the the effect of PTH on the outcome of spinal fusion surgery by analyzing the procedure with Forsteo (PTH) previously used in the University Hospital Basel and the Endonet Clinic, as part of a retrospective, observational study.
Detailed description
Spinal fusion operations have been performed in patients with risk factors related to healing or bony consolidation. A distinction is made between risk factors that can be influenced, such as nicotine consumption or the intake of glucocorticoids, and non-modifiable risk factors, such as diabetes mellitus or chronic obstructive pulmonary disease (COPD), which impair bone formation. The presence of these risk factors leads to an increased rate of unhealed fusions, which is why ways are being sought to reduce them. One possibility, in addition to correcting the modifiable risk factors, is the use of topical or systemic drugs. As early as 2009 and 2010, the effect of parathyroid hormone (PTH) on spinal fusions was investigated in animal experiments. In the studies, a significantly better result was found by therapy with PTH. In 2012, the effect of PTH on the outcome of spinal fusion surgery in post-menopausal women with osteoporosis in his prospective study was investigated, and another study evaluated the optimal duration of PTH therapy. Overall, the studies to date indicate the benefit of pharmaceutical supplemental therapy. For this reason, it was used on a case-by-case basis in patients undergoing spinal surgery at the University Hospital Basel. This study is to review the results cited above by analyzing the procedure with Forsteo (PTH) previously used in the University Hospital Basel and the Endonet Clinic, as part of a retrospective, observational study.
Interventions
OTHERData collection (Laboratory tests, Radiologic diagnostics, Patient data taken from existing medical charts)
Data collection: Bone turnover laboratory parameters: alkaline phosphatase (AP), calcium (corrected for albumin), PTH, Calcidiol (25-OH-D3), N-terminales Kollagen Typ 1 -. Propeptid (P1NP), glomerular filtration rate (GFR), calcium/creatinine (in urine); Radiologic diagnostics: Bone densitometry (DEXA), X-rays, computer tomograms, MRI for analysis of time of the bone healing (or a non-union); Patient data taken from existing medical charts: side effects, tolerability of PTH, patient compliance, presence of previous illnesses as risk factors for the formation of pseudoarthrosis, indication for therapy, time at which therapy started and length of therapy with PTH, precise characterization of the operation (type and whether it is a revision or first operation).
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with spinal (fusion) surgery at the Clinic for Spinal Surgery/ University Hospital Basel * Perioperative osteo-anabolic therapy between January 1st, 2013 and December 31st, 2018.
Exclusion criteria
* Contraindications to PTH therapy * Patients refusing therapy with PTH
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of bone healing | one time assessment at baseline | Time of bone healing is analyzed by radiologic diagnostic, evaluation of patient charts and lab parameter analyses. |
Countries
Switzerland
Outcome results
None listed