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Completed

NCT Number: NCT04980209

The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping

To assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

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Key information

Conditions

Femoroacetabular Impingement Femoracetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Univesity Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

Ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. The study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hip pain;
  • Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration

Exclusion criteria

  • Previous hip surgery;
  • Patients with subosseous cystic degeneration of synovitis

Treatment and study plan

ultrasound evaluation

Device

According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group.

Primary outcomes

  1. VAS scale

    Time frame: 1 year after operation

    Visual analogue scale（VAS）was used to measure the pain score. The minimum and maximum values were 0 and 10. The higher score, the worse pain.

  2. MHHS scale

    Time frame: 1 year after operation

    Modified Harris Hip Score (MHHS) scale was used to measure the symptoms of joint. The minimum and maximum values were 0 and 91. The higher score, the better.

  3. Hip CT

    Time frame: 1 day after operation

    Routine postoperative hip CT was used to understand the joint morphology.

  4. Hip X-ray

    Time frame: 1 day after operation

    Routine hip X-ray at the Dunn position was conducted.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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