NCT05406271

Brief Summary

The purpose of the study is

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

June 1, 2022

Last Update Submit

June 1, 2022

Conditions

Hip Arthrosis

Keywords

hip prosthesiscenter of rotationoffset

Outcome Measures

Primary Outcomes (1)

  • Prosthesis cup position

    inclination, anteversion, centre of rotation of the prosthesis cup. Measurement will be made on post x-rays

    Day 1 after surgery

Secondary Outcomes (1)

  • Prosthesis steam position

    Day 1 after surgery

Study Arms (2)

Hip Prosthesis with intraoperative fluoroscopy

EXPERIMENTAL
Diagnostic Test: Intraoperative fluoroscopy

Hip Prosthesis without intraoperative fluoroscopy

NO INTERVENTION

Interventions

Intraoperative fluoroscopyDIAGNOSTIC_TEST

Impantation of hip prosthesis with intraoperative fluoroscopy

Hip Prosthesis with intraoperative fluoroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for hip replacement surgery

You may not qualify if:

  • pregnancy
  • abnormal anatomy (hip dysplasia, fracture)
  • previous srgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Hospital

Rypin, Kuyavian-Pomeranian Voivodeship, 87-500, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Karol Elster, MD, Phd

CONTACT

+48662128773karol.elster@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD Phd

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

PL(1)