- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892523
Influence of Spinal Deformity on THA
July 25, 2023 updated by: Amr Abdel-Rahman Mazhar, Assiut University
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amr A Mazhar, physician
- Phone Number: 01013612542
- Email: amrmazhar96@gmail.com
Study Contact Backup
- Name: Mohamed M Alaa-Eldin Abdel-Aziz, lecturer
- Phone Number: 01096967747
- Email: mohamed.m.alaa@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
patients from 30 to 70 years old with primary THA and spinal deformity
Description
Inclusion Criteria:
- all patients who had primary THA in 6 month duration
- patients from 30 to 70 years old with primary THA
Exclusion Criteria:
- patients who have ankylosing spondylitis
- patients with revised THA
- patients with associated injuries in lower limb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications of THA mainly hip dislocation and HOOS hip survey
Time Frame: 3 month duration post operatively
|
post-operative hip dislocation
|
3 month duration post operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hatem M Abdel-Moneim Bakr, professor, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Blizzard 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 8, 2023
Primary Completion (Estimated)
November 8, 2024
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
May 25, 2023
First Submitted That Met QC Criteria
May 28, 2023
First Posted (Actual)
June 7, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- spinal deformity in THA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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