NCT05264610

Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal (Fusion) Surgery

Interventions

Type	Name	Description
OTHER	Data 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).

Timeline

• Start date: 2021-07-20
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2022-03-03
• Last updated: 2024-03-04

Locations

1 site across 1 country: Switzerland