NCT06037278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

September 7, 2023

Last Update Submit

September 7, 2023

Conditions

Pelvic OsteotomyAcetabular DysplasiaPeriacetabular Osteotomy

Keywords

Customised surgical guides

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months post-surgery

Secondary Outcomes (3)

  • Proof of concept

    12 months

  • i-hot12 questionnaire

    12 months post-surgery

  • Eq-5D

    12 months post-surgery

Study Arms (1)

MyPAO use

OTHER

SIngle arm study, use of device

Device: MyPAO

Interventions

MyPAODEVICE

use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia

Also known as: periacetabular osteotomy
MyPAO use

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · Age greater than 18 years
  • Patient undergoing pelvic osteotomy

You may not qualify if:

  • · 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Orthopaedic Hospital NHS Trust

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

July 13, 2023

Primary Completion

December 31, 2024

Study Completion

September 30, 2025

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)