THANCT05892523
Influence of Spinal Deformity on THA
An observational study of THA, run by Assiut University.
Trial summary
The aim of the study is to understand the effect of spinal deformity and altered sagittal plane parameters of lumbosacral complex on acetabular cup position in THA. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- THA
- What is being tested?
- THA
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2023to 1 Jan 2025
- 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 30 to 70 years
- All sexes
- Adult, Older adult
Study population: patients from 30 to 70 years old with primary THA and spinal deformity
Who may be able to join
- all patients who had primary THA in 6 month duration
- patients from 30 to 70 years old with primary THA
Who cannot join
- patients who have ankylosing spondylitis
- patients with revised THA
- patients with associated injuries in lower limb
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Spinal Deformity on Acetabular Cup Position in THA.
The aim of the study is to understand the effect of spinal deformity and altered sagittal plane parameters of lumbosacral complex on acetabular cup position in THA.
Read the detailed description
Investigators will Find out if there is change in the acetabular cup including the abduction and anteversion angles in patients who had THA and has spinal deformity
- Conditions
- THA
- Being tested
- THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THAProcedure or surgery
positioning the acetabular cup regarding abduction and anteversion angles with or without concern to spinal deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
change of acetabular cup position in spinal deformity
change of acetabular cup abduction and anteversion angles in patients who has THA and spinal deformity
Measured: immediate post operative X-ray hip anteroposterior and cross table lateral views in supine position measuring cup abduction and anteversion angles and 3 month post operative X-ray hip and lumbosacral anteroposterior and lateral views in standing position
Secondary outcomes (1)
complications of THA mainly hip dislocation and HOOS hip survey
post-operative hip dislocation
Measured: 3 month duration post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start8 Nov 2023 (estimated)
- Primary completion8 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for THAStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Rahman Mazhar, Assiut University
- Investigators
- Hatem M Abdel-Moneim Bakr, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892523
- Sponsor's protocol ID
- spinal deformity in THA
- Status last verified
- Jul 2023
- First submitted
- 25 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Phan D, Bederman SS, Schwarzkopf R. The influence of sagittal spinal deformity on anteversion of the acetabular component in total hip arthroplasty. Bone Joint J. 2015 Aug;97-B(8):1017-23. doi: 10.1302/0301-620X.97B8.35700.
PubMed 26224815Blizzard DJ, Nickel BT, Seyler TM, Bolognesi MP. The Impact of Lumbar Spine Disease and Deformity on Total Hip Arthroplasty Outcomes. Orthop Clin North Am. 2016 Jan;47(1):19-28. doi: 10.1016/j.ocl.2015.08.005.
PubMed 26614917
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Spinal Deformity on Acetabular Cup Position in THA.
- ClinicalTrials.gov ID
- NCT05892523
- Acronym / sponsor ID
- spinal deformity in THA
- Conditions
- THA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (estimated)
- Primary completion
- 8 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Jun 2023 (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 the study is to understand the effect of spinal deformity and altered sagittal plane parameters of lumbosacral complex on acetabular cup position in THA.
Detailed description
Investigators will Find out if there is change in the acetabular cup including the abduction and anteversion angles in patients who had THA and has spinal deformity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients from 30 to 70 years old with primary THA and spinal deformity
Key inclusion criteria (2 listed)
- all patients who had primary THA in 6 month duration
- patients from 30 to 70 years old with primary THA
Key exclusion criteria (3 listed)
- patients who have ankylosing spondylitis
- patients with revised THA
- patients with associated injuries in lower limb
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 |
|---|---|---|
| THApositioning the acetabular cup regarding abduction and anteversion angles with or without concern to spinal deformity | Procedure or surgery | – |
Primary outcome
change of acetabular cup position in spinal deformity
Time frame: immediate post operative X-ray hip anteroposterior and cross table lateral views in supine position measuring cup abduction and anteversion angles and 3 month post operative X-ray hip and lumbosacral anteroposterior and lateral views in standing position
change of acetabular cup abduction and anteversion angles in patients who has THA and spinal deformity
1 secondary outcome
complications of THA mainly hip dislocation and HOOS hip survey
Time frame: 3 month duration post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 26224815Phan D, Bederman SS, Schwarzkopf R. The influence of sagittal spinal deformity on anteversion of the acetabular component in total hip arthroplasty. Bone Joint J. 2015 Aug;97-B(8):1017-23. doi: 10.1302/0301-620X.97B8.35700.
- Background: PubMed 26614917Blizzard DJ, Nickel BT, Seyler TM, Bolognesi MP. The Impact of Lumbar Spine Disease and Deformity on Total Hip Arthroplasty Outcomes. Orthop Clin North Am. 2016 Jan;47(1):19-28. doi: 10.1016/j.ocl.2015.08.005.
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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.
Hatem M Abdel-Moneim Bakr, professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of THA, 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 2 inclusion and 3 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 27 Jul 2023. 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?
Contact Amr A Mazhar, physician (01013612542, amrmazhar96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of acetabular cup position in spinal deformity (time frame: immediate post operative X-ray hip anteroposterior and cross table lateral views in supine position measuring cup abduction and anteversion angles and 3 month post operative X-ray hip and lumbosacral anteroposterior and lateral views in standing position). 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 NCT05892523, which also lists 2 linked publications.
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 27 Jul 2023.