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

September 7, 2023 updated by: The Royal Orthopaedic Hospital NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MyPAO use
SIngle arm study, use of device
Device: MyPAO
use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia
Other Names:
  • periacetabular osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product safety assessment
Time Frame: 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.
3 months post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Orthopaedic Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROH22ORTH13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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