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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Osteotomy, Acetabular Dysplasia, Periacetabular Osteotomy

Intervention / Treatment
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* Device: MyPAO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MyPAO use<br>SIngle arm study, use of device | Device: MyPAO<br>* use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia<br>* Other names: periacetabular osteotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| i-hot12 questionnaire | hip-specific health related quality of life outcome tool | 12 months post-surgery | 
| Eq-5D | validated measure of health-related quality of life | 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Customised surgical guides