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Completed

NCT Number: NCT05929105

AI-assisted Preoperative Planning Technology for THA for DDH

In this study, the investigators retrospectively collected DDH case data of THA assisted by AI 3D planning and THA assisted by traditional planning. The compliance between preoperative planning and the type of prosthesis used in the operation, the position of the acetabular prosthesis, the correction of LLD and the postoperative joint function score were analysed to evaluate the short-term effect of AI combined with preoperative 3D planning in THA for DDH.

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Key information

Conditions

Developmental Dysplasia of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750001, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DDH was diagnosed by clinical signs and imaging examination, and a primary THA was planned;
  • the patient had persistent unilateral hip pain, which seriously affected their quality of life;
  • the standard posterolateral approach was used;
  • the contralateral hip was normal or had received THA;
  • the proximal femoral Dorr classification was type A or B;
  • The acetabular classification was Crowe type Ⅰ, Ⅱ, Ⅲ or IV;
  • all patients were treated with the bioartificial hip joint PINNACLE® cup or SUMMIT® stem, developed by Johnson & Johnson Biological.

Exclusion criteria

  • preoperative and postoperative imaging examinations did not meet the evaluation criteria (non-standard double-hip anteroposterior film, acetabular angle and LL length could not be accurately measured);
  • severe osteoporosis, tumour or metabolic disease around the affected hip joint;
  • spinal deformity by other causes or a history of lumbar internal fixation;
  • external deformity of the affected hip joint in the lower extremity;
  • neuromuscular insufficiency (with hip abduction weakness and poliomyelitis);
  • severe disease with intolerance to surgery.

Treatment and study plan

artificial intelligence (AI)-assisted three-dimensional preoperative planning technology

Procedure

In the AI planning group, AI was used to assist in the 3D planning to complete the preoperative design. Preoperative planning was performed by two experienced surgeons and without the chief physician to ensure that the results of the preoperative planning did not affect the selection of intraoperative procedures and prosthesis size.

X-ray film template for 2D planning

Other

A traditional X-ray film template was used to complete the preoperative design in the traditional planning group. The position and size of the prosthesis, the level of femoral neck osteotomy, the length of the LLs and the restoration of eccentricity were estimated by X-ray. A plastic template provided by the manufacturer was used to take the line of the lower edge of the teardrop on both sides as the horizontal reference line, and the acetabular template was placed at 40 abduction on the inner edge of the teardrop so that the lower edge of the acetabular cup was adjacent to the teardrop. An appropriate type of acetabular component was selected to fill the acetabulum and maintain coverage, and the femoral component that best matched the femoral medullary cavity was chosen. The height of the osteotomy was determined, and the planning model was recorded after the surgeons were happy with the placement and outcome.

Primary outcomes

  1. Type of acetabular cup and femoral stem

    Time frame: 31 months

    Accuracy analysis of planning model and the practical model

  2. Difference in the length of lower limbs before and after surgery

    Time frame: 31 months

    Prove the accuracy of the artificial intelligence planning group

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Short-term Outcome of Artificial Intelligence-assisted Preoperative Three-dimensional Planning of Total Hip Arthroplasty for Developmental Dysplasia of the Hip Compared With Traditional Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

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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