Post-Traumatic KyphosisNCT05644574
Surgical Management of Post-Traumatic Kyphosis
An observational study of Post-Traumatic Kyphosis, run by Assiut University.
Trial summary
The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question[s]it aims to answer are: Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Kyphosis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 May 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with age range from 18-65 years old with PTK underwent posterior only corrective surgery and have been followed for at least 2 years with complete documentation.
Who may be able to join
- All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation.
Who cannot join
- Traumatic cervical spine deformities
- Pathologic fracture spine
- Congenital or developmental cases
- Degenerative cases
About this study
Official title: Posterior Surgical Management of Post-Traumatic Kyphosis
The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question[s]it aims to answer are:
Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.
- Conditions
- Post-Traumatic Kyphosis
- Keywords
- Post-Traumatic Kyphosis, Posterior only surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
change in degree of kyphosis
we will measure the kyphosis in pre operative radiogragh and post operative radiograph to detect the change in the degree and the correction achieved after posterior only operative correction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic KyphosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haytham AlmEdden Ahmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644574
- Sponsor's protocol ID
- Surgery in PTK
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Surgical Management of Post-Traumatic Kyphosis
- ClinicalTrials.gov ID
- NCT05644574
- Acronym / sponsor ID
- Surgery in PTK
- Conditions
- Post-Traumatic Kyphosis
- Keywords
- Post-Traumatic Kyphosis, Posterior only surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Dec 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.
The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question[s]it aims to answer are:
Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with age range from 18-65 years old with PTK underwent posterior only corrective surgery and have been followed for at least 2 years with complete documentation.
Key inclusion criteria (1 listed)
- All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation.
Key exclusion criteria (4 listed)
- Traumatic cervical spine deformities
- Pathologic fracture spine
- Congenital or developmental cases
- Degenerative cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in degree of kyphosis
Time frame: 2 years
we will measure the kyphosis in pre operative radiogragh and post operative radiograph to detect the change in the degree and the correction achieved after posterior only operative correction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Kyphosis, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
change in degree of kyphosis (time frame: 2 years). 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 9 Dec 2022.