AI-assisted Preoperative Planning Technology for THA for DDH

NCT05929105 | Completed

• 1 other identifier: lipeng2023
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (2)

• Type of acetabular cup and femoral stem

  Accuracy analysis of planning model and the practical model

  31 months

• Difference in the length of lower limbs before and after surgery

  Prove the accuracy of the artificial intelligence planning group

  31 months

Study Arms (2)

observation group

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

control group

Other: X-ray film template for 2D planning

Interventions

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.

observation group

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.

control group

Eligibility Criteria

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

Study Population

Patients with DDH who underwent unilateral primary THA between January 2020 and July 2022 in the orthopaedic department.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750001, China

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: January 4, 2020
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)