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

Acetabular Dysplasia Clinical Trial

— MyPAO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037278
• Other study ID #: ROH22ORTH13
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: The Royal Orthopaedic Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital
• Periacetabular Osteotomy

Intervention

Device:
• MyPAO
use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia

Locations

Country	Name	City	State
United Kingdom	The Royal Orthopaedic Hospital NHS Trust	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Orthopaedic Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product safety assessment	evaluate the use of the MyPAOTM technology by reviewing number of device related adverse events, in order to continue to assess product safety as part of post marketing surveillance.	3 months post-surgery
Secondary	Proof of concept	surgeon questionnaires after each case. We will determine technical difficulties in using the device, surgeon satisfaction with the use of guides and the guided correction and the presence of any intra-operative adverse events.	12 months
Secondary	i-hot12 questionnaire	hip-specific health related quality of life outcome tool	12 months post-surgery
Secondary	Eq-5D	validated measure of health-related quality of life	12 months post-surgery