NCT06037278

Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study

MyPAO Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Royal Orthopaedic Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A case series to provide post marketing evaluation of the MyPAO surgical planning and patient specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing the safety of the use of these guides in periacetabular osteotomy surgery.

Detailed description

After enrolment, baseline data will be collected including age, sex and ethnicity of the participant. The radiographic measures of centre edge angle of Wiberg and acetabular inclination will be measured by the surgeon and patient reported outcome measures (PROMS) will be collected. The PROMS collected at usual care timepoints in patients undergoing pelvic osteotomy will be collated for use in the dataset. Peri-operative data, including clinician opinion on ease of use, intraoperative dose of radiation used and device associated adverse events, will be recorded and reported in the results.

Conditions

• Pelvic Osteotomy
• Acetabular Dysplasia
• Periacetabular Osteotomy

Interventions

Type	Name	Description
DEVICE	MyPAO	use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia

Timeline

• Start date: 2023-07-13
• Primary completion: 2024-12-31
• Completion: 2025-09-30
• First posted: 2023-09-14
• Last updated: 2023-09-14

Locations

1 site across 1 country: United Kingdom