NCT05892523

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

May 25, 2023

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change of acetabular cup position in spinal deformity

    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 Outcomes (1)

  • complications of THA mainly hip dislocation and HOOS hip survey

    3 month duration post operatively

Interventions

THAPROCEDURE

positioning the acetabular cup regarding abduction and anteversion angles with or without concern to spinal deformity

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from 30 to 70 years old with primary THA and spinal deformity

You may qualify if:

  • all patients who had primary THA in 6 month duration
  • patients from 30 to 70 years old with primary THA

You may not qualify if:

  • patients who have ankylosing spondylitis
  • patients with revised THA
  • patients with associated injuries in lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26224815BACKGROUND
  • 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.

    PMID: 26614917BACKGROUND

MeSH Terms

Interventions

Tacrine

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hatem M Abdel-Moneim Bakr, professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Amr A Mazhar, physician

CONTACT

Mohamed M Alaa-Eldin Abdel-Aziz, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 7, 2023

Study Start

November 8, 2023

Primary Completion

November 8, 2024

Study Completion

January 1, 2025

Last Updated

July 27, 2023

Record last verified: 2023-07