Diferences in 3D Gait Analysis After Various Types of Total Hip Arthroplasty (3DGAHIP)

June 1, 2026 updated by: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Comparative 3D Gait Analysis: Impact of Total Hip Arthroplasty Stem Anchoring (Metadiaphyseal vs Metaphyseal)

Patients with hip osteoarthritis who were indicated for total hip arthroplasty were prospectively enrolled and randomized to receive either a short (metaphyseal) stem or a conventional (metadiaphyseal) stem hip arthroplasty. Three-dimensional gait analysis was performed regularly (preoperatively and at multiple postoperative time points) to determine whether conservative implants result in superior objective and patient-reported outcomes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Ústí nad Labem Region
      • Ústí nad Labem, Ústí nad Labem Region, Czechia, 40113
        • Masaryk Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • high-grade hip osteoarthritis

Exclusion Criteria:

  • none

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conservative (metaphyseal) stem hip arthroplasty
Hip arthroplasty is performed through a minimally invasive anterolateral hip approach. All replacements are completely non-cemented, articulations include polyethylene or ceramic inserts on ceramic heads. Cups are standardly fixed through press-fit principle, no additional pelvis screws were standardly used. Special curved femoral reamers are used in order to consume as little bone stock as possible (only the metaphysis) and provide a muscle-sparing approach.
Procedure: Conservative Total Hip Arthroplasty
Conservative (metaphyseal) stem Total Hip Arthroplasty
Active Comparator: Conventional (metadiaphyseal) stem hip arthroplasty
Hip arthroplasty is performed through a minimally invasive anterolateral hip approach. All replacements are completely non-cemented, articulations include polyethylene or ceramic inserts on ceramic heads. Cups are standardly fixed through press-fit principle, no additional pelvis screws were standardly used. Standard femoral preparation is performed with prosthesis taking bone stock from the metadiaphyseal area of proximal femur, however, gluteal insertions were preserved in simillar fashion as in metaphyseal implants.
Procedure: Conventional Total Hip Arthroplasty
Conventional (metadiaphyseal) stem Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3D Gait analysis - Gait Profile Score
Time Frame: from preoperative to 1 year postoperative
The Gait Profile Score (GPS) is a numerical index (range 0-10, the lesser the number, the better for the patient). The GPS comprises of the kinematic parameteres that are also called the Gait Variable Scores (hip flexion, rotation and abduction) and the spatiotemporal parameters (step time, step length and step cadence). All of these parameters are also mentioned ad separate outcome measures. The extraction of GPS from the 2 basic data groups was done automaticaly through specialised software which is based on the work of Baker et al. (Baker R, McGinley JL, Schwartz MH, et al. The gait profile score and movement analysis profile. Gait Posture. 2009;30(3):265-269. doi:10.1016/j.gaitpost.2009.05.020).
from preoperative to 1 year postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Modified Harris Hip Score
Time Frame: from preoperative to 1 year postoperative
Total range of the questionnaire is 0-100 points, more points=better patient reported outcome. 90-100 points = excellent result; 80-89 = good result; 70-79 = fair result; < 70 points = poor result.
from preoperative to 1 year postoperative

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Step Time
Time Frame: from preoperative to 1 year postoperative
One of the measured spatiotemporal parameters assessing the duration of a step measured in seconds. The parameter does not have a physiological normative scale.
from preoperative to 1 year postoperative
Hip flexion
Time Frame: from preoperative to 1 year postoperative
One of the kinematic gait parameters = Gait Variable Scores measured in degrees. Physiological range of hip flexion is 0 to 130 degrees, the higher the range, the better for the patient.
from preoperative to 1 year postoperative
Step length
Time Frame: From preoperative to 1 year postoperative
One of the measured spatiotemporal parameters assessing the length of each step measured in meters. The parameter does not have a physiological normative scale.
From preoperative to 1 year postoperative
Step cadence
Time Frame: from preoperative to 1 year postoperative
One of the measured spatiotemporal parameters assessing the number of steps in a minute. The parameter does not have a physiological normative scale.
from preoperative to 1 year postoperative
Hip external rotation
Time Frame: from preoperative to 1 year postoperative
One of the kinematic gait parameters = Gait Variable Scores measured in degrees. Physiological range of hip eternal rotation is 0 to 60 degrees. The higher the range, the better for the patient.
from preoperative to 1 year postoperative
Hip abduction
Time Frame: From preoperative to 1 year postoperative
One of the kinematic gait parameters = Gait Variable Scores measured in degrees. Physiological range of hip abduction is 0 to 45 degress. The higher the range, the better for the patient.
From preoperative to 1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3DGAHIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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