Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia

Acetabular Dysplasia Clinical Trial

Official title:

Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia: a Self-controlled, Diagnostic Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03541122
• Other study ID #: HebeiMUth-003
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. Herein, the investigators describe the protocol to verify three novel X-ray indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios, as the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.

Description:

Acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation.

Current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior X-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. The commonly used measurement indicators include centre-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index (AHI). Moreover, some differences exist in the measurement results between male and female patients. Acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. It is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and Sharp angle.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• No experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery;

• No marked pelvic tilt;

• No hip dislocation;

• No obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis;

• No significant lesions in the pelvis or proximal femur;

• Aged over 16 years;

• Provision of written informed consent.

Exclusion Criteria:

• Those with advanced osteoarthritis;

• Those with osteoarthritis secondary to acetabular dysplasia;

• Those with ankylosing spondylitis involving the hip joint;

• Those with rheumatoid arthritis;

• Those with inflammatory inflammation of the hip joint;

• Those with tumor lesions in the hip joint.

Related Conditions & MeSH terms

• Acetabular Dysplasia
• Hip Dislocation
• Hip Dislocation, Congenital

Intervention

Diagnostic Test:
• pelvic X-ray examinations
Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads.

Locations

Country	Name	City	State
China	Third Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of offshoring index (OFI)	The sensitivity represents the percentage of actual patients who are correctly diagnosed with a disease. A higher sensitivity indicates a higher rate of correct diagnosis for acetabular dysplasia.	One day after hospitalization
Secondary	The specificity of OFI,MUI and TBOI	The specificity represents the percentage of disease-free patients who are correctly diagnosed with no disease. A higher specificity indicates a higher rate of correct diagnosis for acetabular dysplasia.	One day after hospitalization
Secondary	The positive predictive value of OFI,MUI and TBOI	The positive predictive value represents the probability that the patient actually suffer from the disease (true positive rate) in all positive cases.	One day after hospitalization
Secondary	The negative predictive value of OFI,MUI and TBOI	The negative predictive value represents the probability that the patient does not suffer from have the disease. This value is often influenced by the sensitivity, specificity, and prevalence in all cases.	One day after hospitalization
Secondary	The positive likelihood ratio of OFI,MUI and TBOI	The positive likelihood ratio represents the probability of a patient who has the disease testing positive divided by the probability of a patient who does not have the disease testing positive.	One day after hospitalization
Secondary	The negative likelihood ratio of OFI,MUI and TBOI	The negative likelihood ratio represents the probability of a patient who has the disease testing negative divided by the probability of a patient who does not have the disease testing negative.	One day after hospitalization