MyPAO patient specific guides surgical planning
Research type
Research Study
Full title
MyPAO patient specific guides and surgical planning for periacetabular osteotomy; post marketing evaluation study
IRAS ID
318218
Contact name
Peter Wall
Contact email
Sponsor organisation
The Royal Orthopaedic Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Shallow hip sockets are a common cause of pain and disability in young people. Some people can be treated with physiotherapy but when symptoms persist surgeons will discuss the possibility of an operation called a peri acetabular osteotomy. This is a major operation where the surgeon cuts the bones around the hip socket and moves the position of the socket within the pelvis to correct the shallow hip deformity. The socket is then fixed with screws in its new position while the bone heals.
At present the surgeon judges how much to move the socket by looking at x-rays during surgery. It is hard to assess the sockets position in three dimensions looking at a two dimensional x-ray. Medacata International are a large medical devices company. They have developed a three dimensional planning software and custom made patient specific guides to help surgeons know how much to move the socket by and help perform the surgery. This technology has CE markings and is registered with the regulator.
As part of post marketing evaluation we want to ensure the technology is formally assessed in a group of willing participants to check for patient safety, proof of concept, and allow refinement the surgical technique if required.
We will invite 15 patients undergoing peri acetabular osteotomy to participate in this study. The patients preoperative CT scan, which are routinely performed will be encrypted and sent to a Medacta International who will create the custom-made surgical guides for the patient. Surgery will be performed according to normal practice, but the custom-made surgical guides will be used to aid the surgeon in moving the socket to the desired place. We will collect data and report any complications related to the use of the custom-made guides.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0055
Date of REC Opinion
21 Mar 2023
REC opinion
Further Information Favourable Opinion