NCT06847113

Brief Summary

The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 21, 2025

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn

    Walking speed will be measured by 10 meter self-selected and maximal walking speed, respectively. Participant will perform two repetitions of self-selected walking speed, followed by two repetitions of maximal walking speed. Mean, measured by meters per seconds, will be calculated onboth of the two different walking speeds.

    Baseline, 3 months and 12 months after surgery

Secondary Outcomes (4)

  • Sit-to-stand

    Baseline, 3 months and 12 months after surgery

  • One legged stance

    Baseline, 3 months and 12 months after surgery

  • Knee specific function and pain

    Baseline and 12 months

  • EQ5D- Health-related quality of life

    Baseline and 12 months after surgery

Other Outcomes (1)

  • Physical activity

    Baseline and 12 months after surgery

Study Arms (1)

Persons scheduled for knee arthroplasty

Age 55 or over, scheduled for primary uni or total knee arthroplasty, able to walk indepentdently with or without walkingaids, living in the eastern part of Norway within 1-2 hours commute from Oslo, able understand Norwegian for instructions and filling out forms,

Other: Physical function

Interventions

Observe walking speed, both maximal and self-selected, over a 12-months period after knee arthroplasty

Persons scheduled for knee arthroplasty

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with knee osteoarthritis scheduled for knee arthroplasty at Lovisenberg Diaconal Hospital who meet the eligibility criteria

You may not qualify if:

  • Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diaconal Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Brita Stanghelle, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

November 20, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations