Spinal (Fusion) SurgeryNCT05264610
Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.
An observational study of Spinal (Fusion) Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Spinal (Fusion) Surgery
- What is being tested?
- Data collection (Laboratory tests, Radiologic diagnostics, Patient data taken from existing medical charts)
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jul 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Contraindications to PTH therapy
- Patients refusing therapy with PTH
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
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.
Read the 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
- Being tested
- Data collection (Laboratory tests, Radiologic diagnostics, Patient data taken from existing medical charts)
- Keywords
- osteoanabolic treatment, parathyroid hormone (PTH), bone healing disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of bone healing
Time of bone healing is analyzed by radiologic diagnostic, evaluation of patient charts and lab parameter analyses.
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start20 Jul 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal (Fusion) SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Suhm, Prof. Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264610
- Sponsor's protocol ID
- 2021-01201; mu22Rikli2
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.
- ClinicalTrials.gov ID
- NCT05264610
- Acronym / sponsor ID
- 2021-01201; mu22Rikli2
- Conditions
- Spinal (Fusion) Surgery
- Keywords
- osteoanabolic treatment, parathyroid hormone (PTH), bone healing disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to PTH therapy
- Patients refusing therapy with PTH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | – |
Primary outcome
Time of bone healing
Time frame: one time assessment at baseline
Time of bone healing is analyzed by radiologic diagnostic, evaluation of patient charts and lab parameter analyses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Suhm, Prof. Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal (Fusion) Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of bone healing (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.