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

The Royal Orthopaedic Hospital NHS Trust

Status: Enrolling

Conditions: Periacetabular Osteotomy; Acetabular Dysplasia; Pelvic Osteotomy

Treatments: Device: MyPAO

Study type: Interventional

Funder types: Other

Identifiers

NCT06037278

ROH22ORTH13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MyPAO use

Other group

Description:

SIngle arm study, use of device

Treatment:

Device: MyPAO