Developmental Dysplasia of the HipNCT06512506
Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia
An observational study of Developmental Dysplasia of the Hip, run by Peking University Third Hospital at 1 site in China.
Trial summary
On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical… 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?
- non-intervention
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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
- Child, Adult, Older adult
Study population: Diagnosis of borderline hip dysplasia with glenolabial injury. (For example, there are no clinical symptoms of simple critical hip dysplasia, and hip pain may occur when combined with glenolabial injury
Who may be able to join
- Diagnosis of borderline hip dysplasia with glenolabial injury.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital Medicial Science Research Ethics Committee
Beijing
wangjianquan wang, 13801076267, wjqsportsmed@163.com
About this study
On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical measures were improved. Achieve accurate and rapid repair, rehabilitation and functional recovery, serve national fitness, and treat people's injuries
Read the detailed description
Based on the work of the previous research group, we prospective constructed a bidirectional cohort of patients with critical hip dysplasia, and summarized the influencing factors for the surgical prognosis of patients with BDDH, so as to continuously optimize patient selection. On this basis, the cohort size was extended to analyze the difference in efficacy between arthroscopic glenolabial repair and glenolabial repair combined with soft tissue enhancement, and further improve the minimally invasive surgery to promote the efficacy of minimally invasive surgery in BDDH patients
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- non-intervention
- 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.
non-interventionOther
non-intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Harris hip score
It is suitable for the evaluation of therapeutic effect of various hip diseases. The Harris score includes pain, function, deformity and range of motion. The lower the improved Harris score, the worse the postoperative effect.
Measured: Preoperative, 24 months after surgery
PRO rating
Based on Patient-Reported Outcome (PRO) : Questionnaires were completed through face-to-face or telephone interviews. Patients' symptoms, function (activity restriction), pain score, quality of life and time to return to activity were evaluated comprehensively. The lower the PRO score, the worse the postoperative effect.
Measured: Preoperative, 24 months after surgery
Cartilage damage outerbridge grading
The patient underwent hip joint MR Examination at 12 months post-operative follow-up with T2 weighted intrachondral defect and high signal
Measured: Preoperative, 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianquan J Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512506
- Sponsor's protocol ID
- M2022046
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia
- ClinicalTrials.gov ID
- NCT06512506
- Acronym / sponsor ID
- M2022046
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical measures were improved. Achieve accurate and rapid repair, rehabilitation and functional recovery, serve national fitness, and treat people's injuries
Detailed description
Based on the work of the previous research group, we prospective constructed a bidirectional cohort of patients with critical hip dysplasia, and summarized the influencing factors for the surgical prognosis of patients with BDDH, so as to continuously optimize patient selection. On this basis, the cohort size was extended to analyze the difference in efficacy between arthroscopic glenolabial repair and glenolabial repair combined with soft tissue enhancement, and further improve the minimally invasive surgery to promote the efficacy of minimally invasive surgery in BDDH patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis of borderline hip dysplasia with glenolabial injury. (For example, there are no clinical symptoms of simple critical hip dysplasia, and hip pain may occur when combined with glenolabial injury
Key inclusion criteria (1 listed)
- Diagnosis of borderline hip dysplasia with glenolabial injury.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| non-interventionnon-intervention | Other | – |
Primary outcome
Improved Harris hip score
Time frame: Preoperative, 24 months after surgery
It is suitable for the evaluation of therapeutic effect of various hip diseases. The Harris score includes pain, function, deformity and range of motion. The lower the improved Harris score, the worse the postoperative effect.
PRO rating
Time frame: Preoperative, 24 months after surgery
Based on Patient-Reported Outcome (PRO) : Questionnaires were completed through face-to-face or telephone interviews. Patients' symptoms, function (activity restriction), pain score, quality of life and time to return to activity were evaluated comprehensively. The lower the PRO score, the worse the postoperative effect.
Cartilage damage outerbridge grading
Time frame: Preoperative, 24 months after surgery
The patient underwent hip joint MR Examination at 12 months post-operative follow-up with T2 weighted intrachondral defect and high signal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Jianquan J Wang, M.D. study chair
Peking University Third Hospital
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 Peking University Third Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianquan Wang, M.D. (13253137009, wjqsportsmed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Harris hip score (time frame: Preoperative, 24 months after surgery). The study lists 3 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 22 Jul 2024.