NCT04791605

Brief Summary

Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 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, 2012

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

9.2 years

First QC Date

March 4, 2021

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty

    Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes

    2 year postop

  • Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty

    Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes

    2 year postop

Study Arms (2)

Gait analysis of cemented total hip

EXPERIMENTAL

Gait analysis of acute collum femoris fracture patient randomized to cemented stem

Other: Gait analysis

Gait analysis of non-cemented total hip

EXPERIMENTAL

Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem

Other: Gait analysis

Interventions

Kinematic and kinetic analysis

Gait analysis of cemented total hipGait analysis of non-cemented total hip

Eligibility Criteria

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

You may qualify if:

  • acute collum femoris fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roland Zügner

Gothenburg, SE 41310, Sweden

Location

Related Publications (1)

  • Zugner R, Tranberg R, Sharegi B, Karrholm J. Gait pattern in patients treated with a total hip arthroplasty due to an acute displaced cervical neck fracture: a randomised comparison between 29 cases with a cemented femoral stem and 16 cases with an uncemented femoral stem. Hip Int. 2024 May;34(3):421-427. doi: 10.1177/11207000231208099. Epub 2023 Dec 12.

MeSH Terms

Conditions

Hip Fractures

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Roland Zügner

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Cemented femur stem Non-cemented femur stem
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

January 1, 2012

Primary Completion

February 28, 2021

Study Completion

March 1, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations