- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630519
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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
-
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Ústí nad Labem Region
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Conventional (metadiaphyseal) stem Total Hip Arthroplasty
|
What is the study measuring?
Primary Outcome Measures
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
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
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.
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)
September 30, 2024
Primary Completion (Actual)
January 30, 2025
Study Completion (Actual)
January 30, 2025
Study Registration Dates
First Submitted
March 30, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 5, 2026
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID 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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