Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia

NCT ID: NCT03541122

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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.

Conditions

Acetabular Dysplasia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group

Patients will undergo pelvic X-ray examinations. Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads. The investigators will determine the sensitivity and specificity of OFI, MUI and TBOI for the diagnosis of adult acetabular dysplasia, and compare the accuracy of diagnosis between these three indicators and CE angle, sharp angle, and AHI. Further analysis of risk factors for hip function will be implemented.

pelvic X-ray examinations

Intervention Type: DIAGNOSTIC_TEST

Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads.

Interventions

pelvic X-ray examinations

Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Di Qin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Di Qin, M.S.

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University

Locations

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HebeiMUth-003

Identifier Type: -

Identifier Source: org_study_id