An interventional study of MyPAO in Pelvic Osteotomy, Acetabular Dysplasia and Periacetabular Osteotomy, sponsored by The Royal Orthopaedic Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by The Royal Orthopaedic Hospital NHS Trust · Not applicable, Interventional, and Treatment
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.
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.
114 studies on the registry are indexed under Developmental Dysplasia of the Hip; 17 are open to participants now.
This study's planned enrollment of 15 is below the median of 61 across 71 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →The Royal Orthopaedic Hospital NHS Trust is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age greater than 18 years
Exclusion Criteria:
Evidence of hip degeneration assessed by the surgeon on x-ray (Tonnis Grade 1 or greater)
SIngle arm study, use of device
Device: MyPAO
use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia
Also known as: periacetabular osteotomy
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.
Time frame: 3 months post-surgery
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.
Time frame: 12 months
i-hot12 questionnaire
hip-specific health related quality of life outcome tool
Time frame: 12 months post-surgery
Eq-5D
validated measure of health-related quality of life
Time frame: 12 months post-surgery
Plan to share: No
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Developmental Dysplasia of the Hip→
The Royal Orthopaedic Hospital NHS Trust