Trials / Not Yet Recruiting
Not Yet RecruitingNCT07493746
Hip Arthroscopy Versus Conservative Treatment for Borderline Hip Dysplasia
Arthroscopic Hip Surgery Versus Individualized Conservative Treatment for Borderline Hip Dysplasia: A Multicenter Prospective Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- Sponsor
- ChunBao Li · Academic / Other
- Sex
- All
- Age
- 18 Years – 42 Years
- Healthy volunteers
- Not accepted
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°. 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Hip arthroscopy | The surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated. |
| COMBINATION_PRODUCT | Individualized conservative treatment | 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. |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-12-12
- Completion
- 2029-06-30
- First posted
- 2026-03-25
- Last updated
- 2026-03-25
Source: ClinicalTrials.gov record NCT07493746. Inclusion in this directory is not an endorsement.