Acetabular Dysplasia, Pelvic Osteotomy, Periacetabular Osteotomy
Conditions
Keywords
Customised surgical guides
Brief 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.
Interventions
DEVICEMyPAO
use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia
Sponsors
The Royal Orthopaedic Hospital NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product safety assessment | 3 months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proof of concept | 12 months | 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. |
| i-hot12 questionnaire | 12 months post-surgery | hip-specific health related quality of life outcome tool |
| Eq-5D | 12 months post-surgery | validated measure of health-related quality of life |
Countries
United Kingdom
Outcome results
None listed