AI-assisted Preoperative Planning Technology for THA for DDH

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05929105
Collaborator
(none)
61
1
33.8
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: artificial intelligence (AI)-assisted three-dimensional preoperative planning technology
  • Other: X-ray film template for 2D planning

Study Design

Study Type:
Observational
Actual Enrollment :
61 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Jan 4, 2020
Actual Primary Completion Date :
Jul 30, 2022
Actual Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
observation group

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

control group

Other: X-ray film template for 2D planning
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.

Outcome Measures

Primary Outcome Measures

  1. Type of acetabular cup and femoral stem [31 months]

    Accuracy analysis of planning model and the practical model

  2. Difference in the length of lower limbs before and after surgery [31 months]

    Prove the accuracy of the artificial intelligence planning group

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750001

Sponsors and Collaborators

  • General Hospital of Ningxia Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peng Li, Deputy Director, General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT05929105
Other Study ID Numbers:
  • lipeng2023
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023