NCT07630519

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 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

September 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

March 30, 2026

Last Update Submit

June 1, 2026

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

  • 3D Gait analysis - Gait Profile Score

    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 Outcomes (1)

  • The Modified Harris Hip Score

    from preoperative to 1 year postoperative

Other Outcomes (6)

  • Step Time

    from preoperative to 1 year postoperative

  • Hip flexion

    from preoperative to 1 year postoperative

  • Step length

    From preoperative to 1 year postoperative

  • +3 more other outcomes

Study Arms (2)

Conservative (metaphyseal) stem hip arthroplasty

ACTIVE COMPARATOR

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

Conventional (metadiaphyseal) stem hip arthroplasty

ACTIVE COMPARATOR

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

Interventions

Conservative Total Hip ArthroplastyPROCEDURE

Conservative (metaphyseal) stem Total Hip Arthroplasty

Conservative (metaphyseal) stem hip arthroplasty
Conventional Total Hip ArthroplastyPROCEDURE

Conventional (metadiaphyseal) stem Total Hip Arthroplasty

Conventional (metadiaphyseal) stem hip arthroplasty

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high-grade hip osteoarthritis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital

Ústí nad Labem, Ústí nad Labem Region, 40113, Czechia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

June 5, 2026

Study Start

September 30, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)