Evaluation of customized surgical guides for pelvic osteotomy
MyPAO Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
This study is testing if customized surgical guides can make pelvic osteotomy surgeries safer and more effective for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | The Royal Orthopaedic Hospital NHS Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT06037278 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of MyPAO surgical planning and patient-specific guides in periacetabular osteotomy surgeries. It involves collecting baseline data on participants, including demographic information and radiographic measures. Patient-reported outcome measures (PROMS) will be gathered at standard care timepoints, and peri-operative data will be recorded to assess the ease of use and any adverse events associated with the surgical guides. The study is conducted at a single center with multiple surgeons participating.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who are scheduled for pelvic osteotomy.
Not a fit: Patients with hip degeneration or known allergies to Polyamide PA12 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical precision and improve recovery outcomes for patients undergoing pelvic osteotomy.
How similar studies have performed: While this specific approach is novel, similar studies evaluating customized surgical guides have shown promising results in other orthopedic procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * · Age greater than 18 years * Patient undergoing pelvic osteotomy Exclusion Criteria: * · Evidence of hip degeneration assessed by the surgeon on x-ray (Tonnis Grade 1 or greater) * Known allergy to Polyamide PA12 * Unable to provide written informed consent
Where this trial is running
Birmingham
- The Royal Orthopaedic Hospital NHS Trust — Birmingham, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.