Hip Arthroscopy Versus Conservative Treatment for Borderline Hip Dysplasia
ConditionDevelopmental Dysplasia of the Hip
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorChunBao Li
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Hip arthroscopy
Procedure/SurgeryThe surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated.
Individualized conservative treatment
Combination productThe conservative treatment protocol includes patient education, NSAIDs for 2-4 weeks, chondroprotective supplementation for 8 weeks, and supervised progressive exercise training for 3 months.
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: Hip arthroscopyExperimental treatment 1 intervention
Group B: Individualized conservative treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-intervention, and at 12 and 24 months post-randomizationSecondary outcomes
1
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.
Time frame
Pre-intervention, and at 12 and 24 months post-randomization2
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.
Time frame
Pre-intervention, and at 12 and 24 months post-randomization3
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.
Time frame
Pre-intervention, and at 12 and 24 months post-randomization4
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.
Time frame
12 and 24 months post-randomizationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ChunBao Li
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov
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