Optimum Radiographic Assessment of the Knee

NCT03685019 | Terminated Results

• 1 other identifier: 256
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0

Secondary Outcomes (1)

• 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

  Day 0

Study Arms (8)

Valgus stress - lateral compartment

EXPERIMENTAL

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

Radiation: Valgus Stress

Varus stress - medial compartment

EXPERIMENTAL

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

Radiation: Varus stress

0 degree flexion - medial compartment

EXPERIMENTAL

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

Radiation: 0 degree flexion radiograph

0 degree flexion - lateral compartment

EXPERIMENTAL

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

Radiation: 0 degree flexion radiograph

20 degree flexion - medial compartment

EXPERIMENTAL

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

Radiation: 20 degree flexion radiograph

20 degree flexion - lateral compartment

EXPERIMENTAL

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

Radiation: 20 degree flexion radiograph

45 degree flexion - medial compartment

EXPERIMENTAL

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

Radiation: 45 degree flexion radiograph

45 degree flexion - lateral compartment

EXPERIMENTAL

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

Radiation: 45 degree flexion radiograph

Interventions

Valgus Stress RADIATION

Valgus stress radiograph

Valgus stress - lateral compartment

Varus stress RADIATION

Varus stress radiograph

Varus stress - medial compartment

0 degree flexion radiograph RADIATION

0 degree flexion radiograph

0 degree flexion - lateral compartment; 0 degree flexion - medial compartment

20 degree flexion radiograph RADIATION

20 degree flexion radiograph

20 degree flexion - lateral compartment; 20 degree flexion - medial compartment

45 degree flexion radiograph RADIATION

45 degree flexion radiograph

45 degree flexion - lateral compartment; 45 degree flexion - medial compartment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Oxford: collaborator

Related Links

• Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Thomas Hamilton
• Organization: University of Oxford

thomas.hamilton@ndorms.ox.ac.uk

01865 227374

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Model Details: Each of the interventions was planned to be applied in sequence.

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: September 26, 2018
• Study Start: October 5, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08