Hip Arthroscopy Versus Conservative Treatment for Borderline Hip Dysplasia

NCT07493746 | Not Yet Recruiting

• 1 other identifier: 2026KY001-HS001
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Developmental Dysplasia of the Hip

Keywords

Borderline hip dysplasia; Arthroscopy; Conservative treatment

Outcome Measures

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.

  Pre-intervention, and at 12 and 24 months post-randomization

Secondary Outcomes (6)

• Visual Analogue Scale

  Pre-intervention, and at 12 and 24 months post-randomization

• International Hip Outcome Tool-12

  Pre-intervention, and at 12 and 24 months post-randomization

• General health: Short Form questionnaire-12 items

  Pre-intervention, and at 12 and 24 months post-randomization

• Patient satisfaction

  12 and 24 months post-randomization

• Clinical assessment

  Pre-intervention, and at 12 and 24 months post-randomization

Study Arms (2)

Hip arthroscopy

EXPERIMENTAL

Procedure: Hip arthroscopy

Individualized conservative treatment

ACTIVE COMPARATOR

Combination Product: Individualized conservative treatment

Interventions

Hip arthroscopy PROCEDURE

The surgical group will undergo standardized hip arthroscopy with capsular management, acetabular rim limited trimming, labral repair, and Cam deformity correction when indicated.

Hip arthroscopy

Individualized conservative treatment COMBINATION_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.

Individualized conservative treatment

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ChunBao Li: lead

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Sports Medicine

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03