Spinal FusionRachideMDSNCT04983576
Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study
An observational study of Spinal Fusion and Surgery--Complications, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Fusion, Surgery--Complications, Spine Disease
- What is being tested?
- spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 393 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2021to 20 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoind spine surgery with arthrodesis
Who may be able to join
- All patients undergoing spine fusion and followed up for clinical checks in the year following the surgery .
Who cannot join
- patients undergoing spine surgery without the application of instrumentation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors.
- Conditions
- Spinal Fusion, Surgery--Complications, Spine Disease
- Being tested
- spinal fusion
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal fusionProcedure or surgery
patients undergoing spinal fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of mechanical failure
number of mechanical failure / total number of spinal fusion performed
Measured: up to 1 year from the surgery
Secondary outcomes (1)
deambulation performed during hospitalization
number of patients that are able to achieve ambulation after surgery
Measured: up to the first day(up to 1 day) for ambulation from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start30 Aug 2021
- Primary completion13 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Peccerillo, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983576
- Sponsor's protocol ID
- CE-AVEC 354/2021/Oss/IOR
- Acronym
- RachideMDS
- Status last verified
- Mar 2022
- First submitted
- 3 Jul 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
A C, V P, R R, A G, Mg B, A E, M M. What are the prognostic factors of early ambulation after spinal arthrodesis surgery? A retrospective study. J Bodyw Mov Ther. 2025 Jun;42:205-210. doi: 10.1016/j.jbmt.2024.12.010. Epub 2024 Dec 10.
PubMed 40325670
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study
- ClinicalTrials.gov ID
- NCT04983576
- Acronym / sponsor ID
- RachideMDS / CE-AVEC 354/2021/Oss/IOR
- Conditions
- Spinal Fusion, Surgery--Complications, Spine Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 30 Jul 2021 (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.
The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoind spine surgery with arthrodesis
Key inclusion criteria (1 listed)
- All patients undergoing spine fusion and followed up for clinical checks in the year following the surgery .
Key exclusion criteria (1 listed)
- patients undergoing spine surgery without the application of instrumentation
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 |
|---|---|---|
| spinal fusionpatients undergoing spinal fusion | Procedure or surgery | – |
Primary outcome
incidence of mechanical failure
Time frame: up to 1 year from the surgery
number of mechanical failure / total number of spinal fusion performed
1 secondary outcome
deambulation performed during hospitalization
Time frame: up to the first day(up to 1 day) for ambulation from the surgery
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 31 Mar 2022.
- Derived from this study: PubMed 40325670A C, V P, R R, A G, Mg B, A E, M M. What are the prognostic factors of early ambulation after spinal arthrodesis surgery? A retrospective study. J Bodyw Mov Ther. 2025 Jun;42:205-210. doi: 10.1016/j.jbmt.2024.12.010. Epub 2024 Dec 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Surgery--Complications, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 1 inclusion and 1 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 31 Mar 2022. 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 Italy. 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?
incidence of mechanical failure (time frame: up to 1 year from the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983576, which also lists 1 linked publication.
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 31 Mar 2022.