Developmental Dysplasia of the HipNCT07493746
Hip Arthroscopy Versus Conservative Treatment for Borderline Hip Dysplasia
A study testing Hip arthroscopy and Individualized conservative treatment in people with Developmental Dysplasia of the Hip, run by ChunBao Li.
Trial summary
The goal of this clinical trial is to compare the efficacy of hip arthroscopy versus individualized conservative treatment in patients with borderline developmental dysplasia of the hip (BDDH), defined by a lateral center-edge angle (LCEA) of 18-25°. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Hip arthroscopy and Individualized conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-42 years (studies have reported age ≥42 years as a risk factor for hip arthroscopy in BDDH: HR=11.6, 95% CI: 2.5-53.9), either sex;
- Symptoms (anterior-lateral groin, lateral, or posterolateral hip pain or discomfort), physical examination findings (limp, clicking, locking, and limited range of motion), and imaging findings consistent with BDDH diagnosis (standing anteroposterior pelvic radiograph with Wiberg lateral center-edge angle [LCEA] 18-25°);
- Surgeon's assessment that the patient with BDDH will benefit from hip arthroscopy or conservative treatment;
- Full understanding of trial benefits and risks, willingness to participate in the intervention and complete follow-up, and signed informed consent.
Who cannot join
- Standing anteroposterior pelvic radiograph showing Tönnis grade ≥2 and/or joint space <2 mm;
- Standing anteroposterior pelvic radiograph showing FEAR index >5°;
- Positive physical examination for joint instability: anterior apprehension test (HEER test), abduction-extension-external rotation test in lateral decubitus position (AB-HEER test), or prone external rotation test;
- History of high-energy hip trauma, previous ipsilateral or contralateral hip surgery, avascular necrosis of the femoral head, slipped capital femoral epiphysis, Perthes disease, severe osteoporosis, tumor, acetabular stress fracture, or hypertrophic or inflammatory hip disease;
- Concomitant consciousness disorder, psychiatric illness, or neuromuscular dysfunction affecting lower limb function;
- Contraindications to hip arthroscopy (such as systemic or local infection).
About this study
Official title: Arthroscopic Hip Surgery Versus Individualized Conservative Treatment for Borderline Hip Dysplasia: A Multicenter Prospective Randomized Controlled Trial
The goal of this clinical trial is to compare the efficacy of hip arthroscopy versus individualized conservative treatment in patients with borderline developmental dysplasia of the hip (BDDH), defined by a lateral center-edge angle (LCEA) of 18-25°. The main question it aims to answer is: which treatment approach, surgical or conservative, provides superior pain relief, functional recovery, and quality of life improvement at 12 and 24 months post randomization? Participants will be randomly assigned (1:1) to either standardized hip arthroscopy, comprising capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated; or a 3-month individualized conservative protocol including patient education, nonsteroidal anti-inflammatory drugs (NSAIDs) for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training. All participants will undergo follow-up assessments at baseline, 12, and 24 months. The primary outcome is the modified Harris Hip Score (mHHS). Secondary outcomes include patient-reported outcome measures (VAS pain, iHOT-12, SF-12, and patient satisfaction), clinical assessments, and safety monitoring.
Read the detailed description
This multicenter, prospective, randomized controlled trial aims to compare the efficacy of hip arthroscopy versus individualized conservative treatment in patients with borderline developmental dysplasia of the hip (BDDH). BDDH, defined by a lateral center-edge angle (LCEA) of 18-25°, represents a distinct condition between normal hips and developmental dysplasia of the hip, and its optimal management remains controversial. A total of 248 eligible patients aged 18-42 years will be recruited from 23 qualified clinical centers across China and randomly assigned (1:1) to either hip arthroscopy surgery or individualized conservative therapy using minimization dynamic randomization stratified by age and LCEA. The conservative treatment protocol includes patient education, NSAIDs for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training for 3 months. The surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated. The primary outcome is the modified Harris Hip Score (mHHS) , with a minimal clinically important difference (MCID) of 9 points and patient-acceptable symptom state (PASS) threshold of 78 points. Secondary outcomes include patient-reported outcome measures (pain VAS, iHOT-12, SF-12, and patient satisfaction), clinical assessments (hip range of motion and impingement tests), and safety monitoring (adverse events recorded up to 24 months).
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Hip arthroscopy, Individualized conservative treatment
- Keywords
- Borderline hip dysplasia; Arthroscopy; Conservative treatment
- 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.
Hip arthroscopyProcedure or surgery
The surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated.
Individualized conservative treatmentCombination product
The conservative treatment protocol includes patient education, NSAIDs for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Hip arthroscopy | Experimental | Not described Receives: Procedure: Hip arthroscopy |
| Individualized conservative treatment | Active comparator | Not described Receives: Combination Product: Individualized conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Harris Hip Score
The primary outcome was the modified Harris Hip Score (mHHS), assessed at pre-intervention, and at 12 and 24 months post-randomization. It is a clinician-reported instrument designed to evaluate hip function, commonly used to assess functional recovery before and after conservative treatment or hip arthroscopy. The scale encompasses domains such as pain, function, joint range of motion, and deformity, providing a total score ranging from 0 to 100, with higher scores indicating better hip function (typically, 90-100 points represent excellent, 80-89 good, 70-79 fair, and <70 poor). The instrument has been validated in a relevant population for this trial, with a minimum clinically important difference of 9 points and a patient-acceptable symptom state threshold of 78 points.
Measured: Pre-intervention, and at 12 and 24 months post-randomization
Secondary outcomes (6)
Visual Analogue Scale
The pain Visual Analogue Scale (VAS) score is a patient-reported instrument designed to quantify pain intensity. It uses a 100-mm line anchored by "no pain" and "worst imaginable pain," with a total score ranging from 0 to 100, where higher scores indicate more severe pain. This instrument has been validated in a relevant population for this trial.
Measured: Pre-intervention, and at 12 and 24 months post-randomization
International Hip Outcome Tool-12
The iHOT-12 (international Hip Outcome Tool-12) score is a patient-reported instrument designed to assess hip-related quality of life. Derived from the full iHOT-33 scale, this 12-item instrument covers domains such as symptoms, functional limitations, sports and recreational activities, and work-related concerns. It provides a total score ranging from 0 to 100, with higher scores indicating better hip function and quality of life.
Measured: Pre-intervention, and at 12 and 24 months post-randomization
General health: Short Form questionnaire-12 items
The 12-Item Short Form Survey (SF-12) is a validated and widely used health-related quality of life measure, commonly applied to assess hip conditions and treatment outcomes. The SF-12 generates the physical and mental component summary scores originally derived from the 36-Item Short Form Survey (SF-36) with considerable accuracy, while significantly reducing respondent burden. This 12-item scale comprises two dimensions: positive mental state and psychological distress symptoms. Scores from all items are summed to obtain a total score, with higher scores indicating more severe psychological distress.
Measured: Pre-intervention, and at 12 and 24 months post-randomization
Patient satisfaction
Patient satisfaction was measured using questions that our team had used in previous trials involving patients undergoing hip arthroscopy for BDDH. During follow-up, we assessed satisfaction in all participants by asking: "Overall, how satisfied are you with the treatment you received?" Responses were rated on a scale from 1 to 10, where 1 indicated dissatisfied and 10 indicated very satisfied.
Measured: 12 and 24 months post-randomization
Clinical assessment
Clinical assessment performed at baseline and follow up visits consisted of range of passive hip movement, measured using a goniometer, and recording whether a participant experienced pain on each movement. Impingement tests determined whether a participant experienced pain on hip flexion, adduction, and internal rotation (FADIR) or flexion, abduction, and external rotation (FABER).
Measured: Pre-intervention, and at 12 and 24 months post-randomization
Adverse events
We recorded the number and type of adverse events up to 24 months. Any adverse events were recorded on the appropriate case report forms and returned to the clinical trial unit, where the chief investigator determined causality and expectedness. Serious adverse events deemed unexpected and related to the trial were reported to the Research Ethics Committee within 10 days.
Measured: post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion12 Dec 2028 (estimated)
- Study completion30 Jun 2029 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChunBao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ChunBao Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493746
- Sponsor's protocol ID
- 2026KY001-HS001
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Hip Surgery Versus Individualized Conservative Treatment for Borderline Hip Dysplasia: A Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07493746
- Acronym / sponsor ID
- 2026KY001-HS001
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- Borderline hip dysplasia; Arthroscopy; Conservative treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- ChunBao LiUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 12 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Mar 2026 (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.
The goal of this clinical trial is to compare the efficacy of hip arthroscopy versus individualized conservative treatment in patients with borderline developmental dysplasia of the hip (BDDH), defined by a lateral center-edge angle (LCEA) of 18-25°. The main question it aims to answer is: which treatment approach, surgical or conservative, provides superior pain relief, functional recovery, and quality of life improvement at 12 and 24 months post randomization? Participants will be randomly assigned (1:1) to either standardized hip arthroscopy, comprising capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated; or a 3-month individualized conservative protocol including patient education, nonsteroidal anti-inflammatory drugs (NSAIDs) for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training. All participants will undergo follow-up assessments at baseline, 12, and 24 months. The primary outcome is the modified Harris Hip Score (mHHS). Secondary outcomes include patient-reported outcome measures (VAS pain, iHOT-12, SF-12, and patient satisfaction), clinical assessments, and safety monitoring.
Detailed description
This multicenter, prospective, randomized controlled trial aims to compare the efficacy of hip arthroscopy versus individualized conservative treatment in patients with borderline developmental dysplasia of the hip (BDDH). BDDH, defined by a lateral center-edge angle (LCEA) of 18-25°, represents a distinct condition between normal hips and developmental dysplasia of the hip, and its optimal management remains controversial. A total of 248 eligible patients aged 18-42 years will be recruited from 23 qualified clinical centers across China and randomly assigned (1:1) to either hip arthroscopy surgery or individualized conservative therapy using minimization dynamic randomization stratified by age and LCEA. The conservative treatment protocol includes patient education, NSAIDs for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training for 3 months. The surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated. The primary outcome is the modified Harris Hip Score (mHHS) , with a minimal clinically important difference (MCID) of 9 points and patient-acceptable symptom state (PASS) threshold of 78 points. Secondary outcomes include patient-reported outcome measures (pain VAS, iHOT-12, SF-12, and patient satisfaction), clinical assessments (hip range of motion and impingement tests), and safety monitoring (adverse events recorded up to 24 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip arthroscopy | Experimental | Procedure: Hip arthroscopy |
| Individualized conservative treatment | Active comparator | Combination Product: Individualized conservative treatment |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-42 years (studies have reported age ≥42 years as a risk factor for hip arthroscopy in BDDH: HR=11.6, 95% CI: 2.5-53.9), either sex;
- Symptoms (anterior-lateral groin, lateral, or posterolateral hip pain or discomfort), physical examination findings (limp, clicking, locking, and limited range of motion), and imaging findings consistent with BDDH diagnosis (standing anteroposterior pelvic radiograph with Wiberg lateral center-edge angle [LCEA] 18-25°);
- Surgeon's assessment that the patient with BDDH will benefit from hip arthroscopy or conservative treatment;
- Full understanding of trial benefits and risks, willingness to participate in the intervention and complete follow-up, and signed informed consent.
Key exclusion criteria (6 listed)
- Standing anteroposterior pelvic radiograph showing Tönnis grade ≥2 and/or joint space <2 mm;
- Standing anteroposterior pelvic radiograph showing FEAR index >5°;
- Positive physical examination for joint instability: anterior apprehension test (HEER test), abduction-extension-external rotation test in lateral decubitus position (AB-HEER test), or prone external rotation test;
- History of high-energy hip trauma, previous ipsilateral or contralateral hip surgery, avascular necrosis of the femoral head, slipped capital femoral epiphysis, Perthes disease, severe osteoporosis, tumor, acetabular stress fracture, or hypertrophic or inflammatory hip disease;
- Concomitant consciousness disorder, psychiatric illness, or neuromuscular dysfunction affecting lower limb function;
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 |
|---|---|---|
| Hip arthroscopyThe surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated. | Procedure or surgery | Hip arthroscopy |
| Individualized conservative treatmentThe conservative treatment protocol includes patient education, NSAIDs for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training for 3 months. | Combination product | Individualized conservative treatment |
Primary outcome
The modified Harris Hip Score
Time frame: Pre-intervention, and at 12 and 24 months post-randomization
The primary outcome was the modified Harris Hip Score (mHHS), assessed at pre-intervention, and at 12 and 24 months post-randomization. It is a clinician-reported instrument designed to evaluate hip function, commonly used to assess functional recovery before and after conservative treatment or hip arthroscopy. The scale encompasses domains such as pain, function, joint range of motion, and deformity, providing a total score ranging from 0 to 100, with higher scores indicating better hip function (typically, 90-100 points represent excellent, 80-89 good, 70-79 fair, and <70 poor). The instrument has been validated in a relevant population for this trial, with a minimum clinically important difference of 9 points and a patient-acceptable symptom state threshold of 78 points.
6 secondary outcomes
Visual Analogue Scale
Time frame: Pre-intervention, and at 12 and 24 months post-randomization
International Hip Outcome Tool-12
Time frame: Pre-intervention, and at 12 and 24 months post-randomization
General health: Short Form questionnaire-12 items
Time frame: Pre-intervention, and at 12 and 24 months post-randomization
Patient satisfaction
Time frame: 12 and 24 months post-randomization
Clinical assessment
Time frame: Pre-intervention, and at 12 and 24 months post-randomization
Adverse events
Time frame: post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Related trials for Developmental Dysplasia of the Hip
Not yet recruiting
Improving Neonatal Hip Screening With Artificial Intelligence
Developmental Dysplasia of Hip
Not yet recruiting
8 vs 12 Weeks: A Pavlik Harness Trial
Developmental Dysplasia of Hip, DDH
Recruiting
Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem
Osteoarthritis, Hip, Femur Head Necrosis
Not yet recruiting
Manual Intervention and Congenital Hip Dysplasia in Infants
Developmental Dysplasia of the Hip (DDH), Congenital Hip Dysplasia
RecruitingObservational study
Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies
Developmental Dysplasia of the Hip (DDH), Developmental Dysplasia of the Hip
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hip arthroscopy and Individualized conservative treatment in people with Developmental Dysplasia of the Hip, run by ChunBao Li.
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 4 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The modified Harris Hip Score (time frame: Pre-intervention, and at 12 and 24 months post-randomization). 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 25 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.