Clinical trial NCT05264610: Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.
Official title: Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal (Fusion) Surgery
Keywords: osteoanabolic treatment
parathyroid hormone (PTH)
bone healing disorder
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the Clinic for Spinal Surgery/ University Hospital Basel who, in cooperation with the Endonet Clinic Basel, underwent perioperative osteo-anabolic therapy between January 1st, 2013 and December 31st, 2018.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of bone healing
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Norbert Suhm, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: