Brief Summary

X-rays are the most frequently used imaging test when evaluating the knee for joint replacement. They are non-invasive, safe and cost effective. They allow assessment of: progression of disease, appropriateness for joint replacement (in particular unicompartmental knee replacement (UKR)) as well as likely prognosis following replacement. Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray views. In addition in patients being considered for joint replacement valgus/varus stress X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament) and medial compartment respectively to assess the status of the cartilage. Stress X-rays require the clinician to attend X-ray, often during busy clinics, exposing them to additional radiation, and as such they are seldom performed. A patient and user friendly device for performing valgus and varus stress X-rays of the knee for diagnostic and pre-operative planning purposes in the setting of knee replacement surgery has been developed. This device has the potential to benefit patients as it will allow an accurate assessment of the pattern and severity of arthritis affecting their knee without the need for additional diagnostics such as MRI or arthroscopy. Furthermore for healthcare practitioners and providers this device will facilitate the smooth running of clinics and reduce the additional clinic appointments required to review MRI results. Ultimately this device will allow an informed discussion about treatment options, reduce the pre-operative uncertainty about suitability for UKR in those undergoing surgery and ensure that those patients who are suitable for UKR benefit from this procedure. This device will help ensure that patients receive the optimum treatment in a clinically and cost efficient manner. This study will validate valgus and varus stress X-rays performed using the investigators' device against the gold standard of clinician performed manual stress.

Trial Health

100

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jan 2016

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

11 months study duration

First Submitted

Initial submission to the registry

April 27, 2015

Completed

17 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed

8 months until next milestone

Study Start

First participant enrolled

January 13, 2016

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed

Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

April 27, 2015

Results QC Date

September 24, 2018

Last Update Submit

October 7, 2021

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

Compartment Specific Knee Minimum Joint Space Width (Varus - Medial Compartment, Valgus - Lateral Compartment)
Knee minimum joint space width measured on anteroposterior fluoroscopic images using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
Day 0

Secondary Outcomes (1)

Pain (VAS 0 - 10)
At time of procedure

Study Arms (10)

Clinician Valgus

ACTIVE COMPARATOR

Clinician performed fluoroscopic valgus and varus stress X-rays

Radiation: Clinician Valgus

Clinician Varus

ACTIVE COMPARATOR

Clinician performed fluoroscopic varus stress X-rays

Radiation: Clinician Varus

Device Valgus - 0 Newton force

EXPERIMENTAL

Device performed fluoroscopic valgus stress X-rays - 0 Newton force

Radiation: Device Valgus - 0 Newton

Device Valgus - 10 Newton force

EXPERIMENTAL

Device performed fluoroscopic valgus stress X-rays - 10 Newton force

Radiation: Device Valgus - 10 Newton

Device Valgus - 20 Newton force

EXPERIMENTAL

Device performed fluoroscopic valgus stress X-rays - 20 Newton force

Radiation: Device Valgus - 20 Newton

Device Valgus - 30 Newton force

EXPERIMENTAL

Device performed fluoroscopic valgus stress X-rays - 30 Newton force

Radiation: Device Valgus - 30 Newton

Device Varus - 0 Newton force

EXPERIMENTAL

Device performed fluoroscopic varus stress X-rays - 0 Newton force

Radiation: Device Varus - 0 Newton

Device Varus - 10 Newton force

EXPERIMENTAL

Device performed fluoroscopic varus stress X-rays - 10 Newton force

Radiation: Device Varus - 10 Newton

Device Varus - 20 Newton force

EXPERIMENTAL

Device performed fluoroscopic varus stress X-rays - 20 Newton force

Radiation: Device Varus - 20 Newton

Device Varus - 30 Newton force

EXPERIMENTAL

Device performed fluoroscopic varus stress X-rays - 30 Newton force

Radiation: Device Varus - 30 Newton

Interventions

Clinician ValgusRADIATION

Clinician performed valgus stress X-ray under fluoroscopy

Clinician Valgus

Clinician VarusRADIATION

Clinician performed varus stress X-ray under fluoroscopy

Clinician Varus

Device Valgus - 0 NewtonRADIATION