search
Back to results

Optimum Radiographic Assessment of the Knee

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valgus Stress
Varus stress
0 degree flexion radiograph
20 degree flexion radiograph
45 degree flexion radiograph
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Valgus stress - lateral compartment

    Varus stress - medial compartment

    0 degree flexion - medial compartment

    0 degree flexion - lateral compartment

    20 degree flexion - medial compartment

    20 degree flexion - lateral compartment

    45 degree flexion - medial compartment

    45 degree flexion - lateral compartment

    Arm Description

    Valgus stress radiograph. Joint space width measured in lateral compartment.

    Varus stress radiograph. Joint space width measured in medial compartment.

    0 degree flexion radiograph. Joint space width measured in medial compartment.

    0 degree flexion radiograph. Joint space width measured in medial compartment.

    20 degree flexion radiograph. Joint space width measured in medial compartment.

    20 degree flexion radiograph. Joint space width measured in lateral compartment.

    45 degree flexion radiograph. Joint space width measured in medial compartment.

    45 degree flexion radiograph. Joint space width measured in lateral compartment.

    Outcomes

    Primary Outcome Measures

    Knee minimum joint space width (medial and lateral compartment)
    Knee minimum joint space width (medial and lateral compartment) measured using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).

    Secondary Outcome Measures

    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
    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.

    Full Information

    First Posted
    May 7, 2015
    Last Updated
    September 27, 2019
    Sponsor
    Oxford University Hospitals NHS Trust
    Collaborators
    University of Oxford
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03685019
    Brief Title
    Optimum Radiographic Assessment of the Knee
    Official Title
    Optimum Radiographic Assessment of the Medial and Lateral Tibiofemoral Compartments Within the Arthritic Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Failure to recruit
    Study Start Date
    October 5, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oxford University Hospitals NHS Trust
    Collaborators
    University of Oxford

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Valgus stress - lateral compartment
    Arm Type
    Experimental
    Arm Description
    Valgus stress radiograph. Joint space width measured in lateral compartment.
    Arm Title
    Varus stress - medial compartment
    Arm Type
    Experimental
    Arm Description
    Varus stress radiograph. Joint space width measured in medial compartment.
    Arm Title
    0 degree flexion - medial compartment
    Arm Type
    Experimental
    Arm Description
    0 degree flexion radiograph. Joint space width measured in medial compartment.
    Arm Title
    0 degree flexion - lateral compartment
    Arm Type
    Experimental
    Arm Description
    0 degree flexion radiograph. Joint space width measured in medial compartment.
    Arm Title
    20 degree flexion - medial compartment
    Arm Type
    Experimental
    Arm Description
    20 degree flexion radiograph. Joint space width measured in medial compartment.
    Arm Title
    20 degree flexion - lateral compartment
    Arm Type
    Experimental
    Arm Description
    20 degree flexion radiograph. Joint space width measured in lateral compartment.
    Arm Title
    45 degree flexion - medial compartment
    Arm Type
    Experimental
    Arm Description
    45 degree flexion radiograph. Joint space width measured in medial compartment.
    Arm Title
    45 degree flexion - lateral compartment
    Arm Type
    Experimental
    Arm Description
    45 degree flexion radiograph. Joint space width measured in lateral compartment.
    Intervention Type
    Radiation
    Intervention Name(s)
    Valgus Stress
    Intervention Description
    Valgus stress radiograph
    Intervention Type
    Radiation
    Intervention Name(s)
    Varus stress
    Intervention Description
    Varus stress radiograph
    Intervention Type
    Radiation
    Intervention Name(s)
    0 degree flexion radiograph
    Intervention Description
    0 degree flexion radiograph
    Intervention Type
    Radiation
    Intervention Name(s)
    20 degree flexion radiograph
    Intervention Description
    20 degree flexion radiograph
    Intervention Type
    Radiation
    Intervention Name(s)
    45 degree flexion radiograph
    Intervention Description
    45 degree flexion radiograph
    Primary Outcome Measure Information:
    Title
    Knee minimum joint space width (medial and lateral compartment)
    Description
    Knee minimum joint space width (medial and lateral compartment) measured using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Optimum Radiographic Assessment of the Knee

    We'll reach out to this number within 24 hrs