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

NCT ID: NCT06037278

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Osteotomy Acetabular Dysplasia Periacetabular Osteotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MyPAO use

SIngle arm study, use of device

Group Type OTHER

MyPAO

Intervention Type DEVICE

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

Interventions

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MyPAO

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

Intervention Type DEVICE

Other Intervention Names

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periacetabular osteotomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Orthopaedic Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Royal Orthopaedic Hospital NHS Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Gareth Mr Stephens, BSc

Role: primary

[email protected]
01216854316

sam papadopoullos, BSc

Role: backup

[email protected]
01216854316

Other Identifiers

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ROH22ORTH13

Identifier Type: -

Identifier Source: org_study_id

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