NCT04788719

Brief Summary

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 5, 2021

Last Update Submit

September 8, 2021

Conditions

Gait AnalysisHip ArthritisTotal Hip Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Kinematics

    Hip angels in 3 planes

    Preop

  • Kinematics

    Hip angels in 3 planes

    Postop 2 year

Study Arms (2)

Preoperative

EXPERIMENTAL

Gait analysis kinematics and kinetics

Other: Gait analysis

Postoperative

EXPERIMENTAL

Gait analysis kinematics and kinetics

Other: Gait analysis

Interventions

Gait analysisOTHER

Gait analysis

Also known as: Kinematics and kinetics
PostoperativePreoperative

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • hip arthritis

You may not qualify if:

  • no hip arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roland Zügner

Gothenburg, SE 41310, Sweden

Location

MeSH Terms

Interventions

Gait AnalysisBiomechanical PhenomenaKinetics

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation CharacteristicsBiophysical PhenomenaPhysical PhenomenaMechanical PhenomenaBiochemical PhenomenaChemical Phenomena

Study Officials

  • Roland Zügner

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Preop Postop
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

March 1, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Plan to make individual participant data (IPD) after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication
Access Criteria
After publication

Locations

SE(1)