Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
8 participants
INTERVENTIONAL
2016-10-05
2017-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of a Stress Device for the Knee
NCT02444663
The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement
NCT02748096
Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis
NCT03644420
Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit
NCT00862316
Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types
NCT00679120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Valgus stress - lateral compartment
Valgus stress radiograph. Joint space width measured in lateral compartment.
Valgus Stress
Valgus stress radiograph
Varus stress - medial compartment
Varus stress radiograph. Joint space width measured in medial compartment.
Varus stress
Varus stress radiograph
0 degree flexion - medial compartment
0 degree flexion radiograph. Joint space width measured in medial compartment.
0 degree flexion radiograph
0 degree flexion radiograph
0 degree flexion - lateral compartment
0 degree flexion radiograph. Joint space width measured in medial compartment.
0 degree flexion radiograph
0 degree flexion radiograph
20 degree flexion - medial compartment
20 degree flexion radiograph. Joint space width measured in medial compartment.
20 degree flexion radiograph
20 degree flexion radiograph
20 degree flexion - lateral compartment
20 degree flexion radiograph. Joint space width measured in lateral compartment.
20 degree flexion radiograph
20 degree flexion radiograph
45 degree flexion - medial compartment
45 degree flexion radiograph. Joint space width measured in medial compartment.
45 degree flexion radiograph
45 degree flexion radiograph
45 degree flexion - lateral compartment
45 degree flexion radiograph. Joint space width measured in lateral compartment.
45 degree flexion radiograph
45 degree flexion radiograph
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Valgus Stress
Valgus stress radiograph
Varus stress
Varus stress radiograph
0 degree flexion radiograph
0 degree flexion radiograph
20 degree flexion radiograph
20 degree flexion radiograph
45 degree flexion radiograph
45 degree flexion radiograph
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Oxford University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Hamilton
Primary investigator
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
256
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.