Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia

NCT03541122 | Unknown DMC

• 1 other identifier: HebeiMUth-003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetabular Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The specificity of OFI,MUI and TBOI

  One day after hospitalization

• The positive predictive value of OFI,MUI and TBOI

  One day after hospitalization

• The negative predictive value of OFI,MUI and TBOI

  One day after hospitalization

• The positive likelihood ratio of OFI,MUI and TBOI

  One day after hospitalization

• The negative likelihood ratio of OFI,MUI and TBOI

  One day after hospitalization

Study Arms (1)

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.

Diagnostic Test: pelvic X-ray examinations

Interventions

pelvic X-ray examinations DIAGNOSTIC_TEST

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

Experimental group

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential patients will be informed of the study details through an announcement issued through the bulletin board of the Third Hospital of Hebei Medical University. Interested patients will directly contact the principle investigator via telephone, and among them, eligible patients will be required to provide written consent prior to the participation in the trial.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Di Qin, M.S.

  Third Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: February 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

CN (1)