NCT05676437

Brief Summary

Total knee replacement (TKR) instability is a poorly defined entity. The diagnosis is based on symptoms and clinical tests of knee laxity. A subjective feeling of instability, such as giving away is not always present in the unstable knee; however, the patient will rather have non-specific symptoms like pain and swelling. On the other hand, symptoms of instability may be present without excessive laxity. The evaluation of abnormal laxity is also uncertain due to individual variations of normal laxity and the subjectivity of manual laxity testing. Different instrumented methods have been developed in order to reduce subjective bias. Stress radiography is one such test which has been utilised to objectively measure medial and lateral joint opening during varus/valgus stress and anteroposterior translation when subjected to sagittal stress. The limits of acceptable laxity measured by stress radiography is however not established. The aim of this study is to determine thresholds of acceptable laxity as measured by stress radiography.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 22, 2022

Last Update Submit

January 20, 2023

Conditions

Knee Instability in Total Knee Artrhroplasty

Keywords

knee replacementknee arthroplastyinstabilitystress radiography

Outcome Measures

Primary Outcomes (2)

  • Coronal knee laxity

    Coronal knee laxity measured by stress radiography

    12 months postop

  • Sagittal knee laxity

    Sagittal knee laxity measured by stress radiography

    12 months postop

Secondary Outcomes (2)

  • Agreement between clinical and radiography laxity measurement

    12 months postop

  • Agreement of clinical laxity measurement between different examiners

    12 months postop

Study Arms (2)

Satisfied

Patients that are satisfied with their knee replacement, defined by OKS above PASS.

Diagnostic Test: Stress radiography

Unsatisfied

Patients that are unsatisfied with their knee replacement, defined by OKS below PASS.

Diagnostic Test: Stress radiography

Interventions

Stress radiographyDIAGNOSTIC_TEST

Radiographic examination during clinical stress test of knee laxity

SatisfiedUnsatisfied

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that are operated with primary knee replacement.

You may qualify if:

  • Patients with cruciate retaining (CR) TKR with ≥12 months follow up

You may not qualify if:

  • TKR implants with higher constrained articulations (posterior stabilized (PS), condylar constrained (CC) and hinged implants)
  • Suspected infection
  • Range of motion (ROM) limitations that infers with protocol of stress testing; combined flexion contracture \>30 degrees and flexion deficit \< 80 degrees
  • Suspected instability in contralateral knees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Petrie JR, Haidukewych GJ. Instability in total knee arthroplasty : assessment and solutions. Bone Joint J. 2016 Jan;98-B(1 Suppl A):116-9. doi: 10.1302/0301-620X.98B1.36371.

    PMID: 26733656BACKGROUND

  • Deep K. Collateral ligament laxity in knees: what is normal? Clin Orthop Relat Res. 2014 Nov;472(11):3426-31. doi: 10.1007/s11999-014-3865-6. Epub 2014 Aug 13.

    PMID: 25115587BACKGROUND

  • James EW, Williams BT, LaPrade RF. Stress radiography for the diagnosis of knee ligament injuries: a systematic review. Clin Orthop Relat Res. 2014 Sep;472(9):2644-57. doi: 10.1007/s11999-014-3470-8.

    PMID: 24504647BACKGROUND

Study Officials

  • Bernhard Flatøy, Ph.D

    Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Flatoy, PhD

CONTACT

+4790292932bernhard.flatoy@diakonsyk.no

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share