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Accuracy, Safety, and Learning Curve of Computer-Assisted Navigation for Bernese Periacetabular Osteotomy in DDH: A Prospective Randomized Controlled Trial

Accuracy, Safety, and Learning Curve of Computer-Assisted Navigation for Bernese Periacetabular Osteotomy in DDH: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118061
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Navigation Group:Computer-assisted navigation PAO
Freehand Group:Conventional freehand PAO

Sponsors

The Fourth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Skeletally mature patients aged 18 to 45 years with closed physes; (2) Clinical diagnosis of symptomatic developmental dysplasia of the hip (DDH), characterized by inguinal pain persisting for more than 6 months despite conservative management; (3) Radiographic parameters consistent with DDH, defined as a lateral center-edge angle (LCEA) 10°; (4) Preoperative osteoarthritis classified as Tönnis grade 0 or 1; (5) Good concentric congruency between the femoral head and acetabulum confirmed on preoperative functional radiographs. (6)Voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Moderate to severe osteoarthritis (Tönnis grade = 2) or significant joint space narrowing (< 2 mm); (2) Crowe type III or IV high dislocation, or a severely deformed femoral head precluding concentric reduction; (3) History of prior open hip surgery (including osteotomy or open reduction) or septic arthritis in the affected joint; (4) Concomitant severe neuromuscular disorders (e.g., cerebral palsy, sequelae of poliomyelitis), connective tissue diseases (e.g., Marfan syndrome), or systemic conditions affecting bone healing (e.g., uncontrolled diabetes, active rheumatoid arthritis, severe osteoporosis); (5) Severe deformity requiring concurrent femoral osteotomy; (6) Contraindications to computer-assisted navigation, such as the presence of metallic implants at the surgical site; (7) Inability to comply with the postoperative rehabilitation protocol or concurrent participation in other clinical trials that might interfere with the study results. (8)Intolerance to general anesthesia or severe systemic diseases.

Design outcomes

Primary

MeasureTime frame
Achievement rate of radiographic correction parameters;Intraoperative radiation exposure;Operative time;

Secondary

MeasureTime frame
Complication rate;Hip Functional Scores and Pain Scores;

Countries

China

Contacts

Public ContactYong Li

Senior Department of Orthopedics, the Fourth Medical Center of PLA General Hospital

liyong807@163.com+86 10 6684 8810

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026