Developmental Dysplasia of the HipNCT05929105
AI-assisted Preoperative Planning Technology for THA for DDH
An observational study of Developmental Dysplasia of the Hip, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- artificial intelligence (AI)-assisted three-dimensional preoperative planning technology and X-ray film template for 2D planning
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2020to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with DDH who underwent unilateral primary THA between January 2020 and July 2022 in the orthopaedic department.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750001
About this study
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
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
- Being tested
- artificial intelligence (AI)-assisted three-dimensional preoperative planning technology, X-ray film template for 2D planning
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence (AI)-assisted three-dimensional preoperative planning technologyProcedure or surgery
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 planningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| observation group | Not described Receives: Procedure: artificial intelligence (AI)-assisted three-dimensional preoperative planning technology | |
| control group | Not described Receives: Other: X-ray film template for 2D planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of acetabular cup and femoral stem
Accuracy analysis of planning model and the practical model
Measured: 31 months
Difference in the length of lower limbs before and after surgery
Prove the accuracy of the artificial intelligence planning group
Measured: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start4 Jan 2020
- Primary completion30 Jul 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Li, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929105
- Sponsor's protocol ID
- lipeng2023
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05929105
- Acronym / sponsor ID
- lipeng2023
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Procedure: artificial intelligence (AI)-assisted three-dimensional preoperative planning technology |
| control group | – | Other: X-ray film template for 2D planning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with DDH who underwent unilateral primary THA between January 2020 and July 2022 in the orthopaedic department.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artificial intelligence (AI)-assisted three-dimensional preoperative planning technologyIn 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. | Procedure or surgery | observation group |
| X-ray film template for 2D planningA 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. | Other | control group |
Primary outcome
Type of acetabular cup and femoral stem
Time frame: 31 months
Accuracy analysis of planning model and the practical model
Difference in the length of lower limbs before and after surgery
Time frame: 31 months
Prove the accuracy of the artificial intelligence planning group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of acetabular cup and femoral stem (time frame: 31 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.