Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study (MyPAO)
Primary Purpose
Pelvic Osteotomy, Acetabular Dysplasia, Periacetabular Osteotomy
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MyPAO
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Osteotomy focused on measuring Customised surgical guides
Eligibility Criteria
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
Sites / Locations
- The Royal Orthopaedic Hospital NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MyPAO use
Arm Description
SIngle arm study, use of device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
i-hot12 questionnaire
hip-specific health related quality of life outcome tool
Eq-5D
validated measure of health-related quality of life
Full Information
NCT ID
NCT06037278
First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
The Royal Orthopaedic Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT06037278
Brief Title
Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
Acronym
MyPAO
Official Title
MyPAO Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Orthopaedic Hospital NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Osteotomy, Acetabular Dysplasia, Periacetabular Osteotomy
Keywords
Customised surgical guides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MyPAO use
Arm Type
Other
Arm Description
SIngle arm study, use of device
Intervention Type
Device
Intervention Name(s)
MyPAO
Other Intervention Name(s)
periacetabular osteotomy
Intervention Description
use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia
Primary Outcome Measure Information:
Title
Product safety assessment
Description
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
Secondary Outcome Measure Information:
Title
Proof of concept
Description
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
Title
i-hot12 questionnaire
Description
hip-specific health related quality of life outcome tool
Time Frame
12 months post-surgery
Title
Eq-5D
Description
validated measure of health-related quality of life
Time Frame
12 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Royal Orthopaedic Hospital NHS Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Mr Stephens, BSc
Phone
01216854316
Email
gareth.stephens@nhs.net
First Name & Middle Initial & Last Name & Degree
sam papadopoullos, BSc
Phone
01216854316
Email
sam.papadopoullos@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
We'll reach out to this number within 24 hrs