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

NCT05264610 | Completed

• 1 other identifier: 2021-01201; mu22Rikli2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal (Fusion) Surgery

Keywords

osteoanabolic treatment; parathyroid hormone (PTH); bone healing disorder

Outcome Measures

Primary Outcomes (1)

• Time of bone healing

  Time of bone healing is analyzed by radiologic diagnostic, evaluation of patient charts and lab parameter analyses.

  one time assessment at baseline

Interventions

Data collection (Laboratory tests, Radiologic diagnostics, Patient data taken from existing medical charts) OTHER

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).

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Contraindications to PTH therapy
• Patients refusing therapy with PTH

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Norbert Suhm, Prof. Dr. med.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: July 20, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

CH (1)