- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685019
Optimum Radiographic Assessment of the Knee
Optimum Radiographic Assessment of the Medial and Lateral Tibiofemoral Compartments Within the Arthritic Knee
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. Despite a multitude of standardised views there is a lack of consensus regarding the optimum views to evaluate joint space narrowing within each compartment (lateral, medial and patellofemoral).
This study will evaluate the status of knee cartilage in 225 patients with varying degrees, and patterns, of knee osteoarthritis (OA) using standing extension anteroposterior, 15 degrees flexion posteroanterior, 45 degrees flexion posteroanterior and valgus and varus stress views as well as MRI. These results will be compared to the gold standard imaging technique of stress views as well as to direct measurements of retrieved tissue in those patients who undergo knee replacement surgery. The sensitivity and specificity of each of the imaging techniques at predicting suitability for UKR will be calculated, the optimum imaging views proposed, and ultimately the results of this study will be used to develop a decision aid, based on optimum views, to help clinicians decide between likelihood of a patient being a candidate for UKR based on pre-operative X-ray findings.
Study Overview
Status
Conditions
Detailed Description
The optimum imaging protocol is one that is acceptable to patients, involves the fewest X-rays to obtain the most clinically relevant information and one that utilizes the least resources in terms of staff and equipment. Currently standard assessment involves: standing anteroposterior, lateral and skyline 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. In patients with loss of cartilage on one side, typically medial, but preserved cartilage on the other a UKR, as opposed to total knee replacement (TKR), may be indicated.
Currently there is a lack of consensus amongst orthopaedic surgeons as to the best way to image the knee joint to establish degree and pattern of arthritis. For a long time it has been known that weight bearing views are a better method at establishing the true joint space compared to non-weight bearing views width due to the increased forces across the joint. In addition it is known that full extension views, despite being the most commonly used view, may also underestimate joint space narrowing as in full extension the femur and tibia articulate across an area of the joint that is not typically not involved during activity, and hence can have relatively well preserved cartilage, giving a false impression of the joints disease state. These findings have been adopted, and continue to be adopted, into routine clinical practice and there continues to be an increase in the proportion of surgeons performing standing and semi-flexed views. However the best method of evaluating the disease state in each compartment has yet to be defined.
When deciding between UKR and TKR the detection of the degree and pattern of arthritis is of critical importance. UKR are known to perform poorly in partial thickness disease and require full thickness cartilage in the retained tibiofemoral compartment. To establish whether a patient meets the indications for UKR X-rays are used with stress views being the gold standard, as well as the standard assessment that the studies of long term outcomes on UKR are based. Gibson and Goodfellow, who were first to describe stress X-rays in the workup of a patient for UKR, reported that those patients with a joint space width of more than 5mm in the lateral compartment had intact lateral cartilage during surgery making them appropriate for UKR. More recently Waldstein et al. reported that patients with a lateral joint space width of more than 4mm may be appropriate for UKR however overall they noted poor correlation between joint space width measured on valgus stress views and intra-operative Outerbridge grade.
In addition to the low quantity of evidence regarding the relationship between stress views and intra-operative status of the joint the feasibility of performing stress X-rays also limits their use. Stress X-rays are resource dependent, can be uncomfortable for patients and require an additional practitioner. As such they are often not performed with many clinicians adopting alternative X-ray views, MRI or direct observation via arthroscopy. It has been proposed that standing views with the knee in 15 degrees then 45 degrees flexion may load the medial and lateral compartments respectively and that these views may be an alternative to stress views without the requirement for an additional practitioner. However the outcomes based on these forms of assessment, and the relationship between the joint space width measured using these contemporary techniques has not been reported. An alternative would include a stress device that allows a stress X-ray to be performed without the requirement of the clinician.
This study will evaluate the status of knee cartilage in 225 patients with varying degrees, and patterns, of knee OA using standing extension anteroposterior, 15 degrees flexion posteroanterior, 45 degrees flexion posteroanterior and valgus and varus stress views as well as MRI. These results will be compared to the gold standard imaging technique of stress views as well as to direct measurements of retrieved tissue in those patients who undergo knee replacement surgery. The sensitivity and specificity of each of the imaging techniques at predicting suitability for UKR will be calculated, the optimum imaging views proposed, and ultimately the results of this study will be used to develop a decision aid, based on optimum views, to help clinicians decide between likelihood of a patient being a candidate for UKR based on pre-operative X-ray and MRI findings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Knee osteoarthritis any grade, affecting the tibio-femoral joint
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 50 years or above.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Exclusion Criteria:
- Previous joint replacement on ipsilateral knee
- Previous anterior cruciate ligament reconstruction or injury
- Previous high tibial osteotomy
- Previous intraarticular fracture
- History of Inflammatory arthritis
- Unable to stand with assistance for two minutes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Valgus stress - lateral compartment
Valgus stress radiograph.
Joint space width measured in lateral compartment.
|
Valgus stress radiograph
|
Experimental: Varus stress - medial compartment
Varus stress radiograph.
Joint space width measured in medial compartment.
|
Varus stress radiograph
|
Experimental: 0 degree flexion - medial compartment
0 degree flexion radiograph.
Joint space width measured in medial compartment.
|
0 degree flexion radiograph
|
Experimental: 0 degree flexion - lateral compartment
0 degree flexion radiograph.
Joint space width measured in medial compartment.
|
0 degree flexion radiograph
|
Experimental: 20 degree flexion - medial compartment
20 degree flexion radiograph.
Joint space width measured in medial compartment.
|
20 degree flexion radiograph
|
Experimental: 20 degree flexion - lateral compartment
20 degree flexion radiograph.
Joint space width measured in lateral compartment.
|
20 degree flexion radiograph
|
Experimental: 45 degree flexion - medial compartment
45 degree flexion radiograph.
Joint space width measured in medial compartment.
|
45 degree flexion radiograph
|
Experimental: 45 degree flexion - lateral compartment
45 degree flexion radiograph.
Joint space width measured in lateral compartment.
|
45 degree flexion radiograph
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee minimum joint space width (medial and lateral compartment)
Time Frame: Day 0
|
Knee minimum joint space width (medial and lateral compartment) measured using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of X-ray views at demonstrating full thickness cartilage loss, partial thickness cartilage loss and preserved full thickness cartilage within each compartment (medial & lateral) of the knee
Time Frame: Day 0
|
The gold standard will be grade of arthritis at time of surgery in those patients undergoing knee replacement as part of their routine clinical care. Each compartment will be graded independently. An X-ray demonstrating a joint space width (JSW) of 0mm will be classified as full thickness cartilage loss, a JSW of >0mm but <4mm will be classified as partial thickness cartilage loss and a JSW of 4mm or greater will be classified as preserved full thickness cartilage. The sensitivity of each view at predicting the observed grade of cartilage disease within each compartment at the time of surgery will be recorded. |
Day 0
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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