Primary Objective: To compare the post-operative alignment accuracy of PSI PROPHECY*TAR between a beginning (group A) and an experienced orthopedic surgeon (group B).Secondary Objective: To compare the operative time, complications, and patient-…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in TAR component accuracy between the preoperative and 2-year
postoperative model based on CT scans.
Secondary outcome
Abandonment of PSI per-operative, percentage of accurately aligned components,
percentage of accurately predicted implant size (both talar rand tibia
components), patient-reported outcome measures (PROM), and complication and
revision rate.
Background summary
Patient Specific Instrumentation (PSI) is thought to quicken the process by
shortening the operation time and improve alignment. Studies about the learning
curve of PSI for total ankle replacement (TAR) are lacking because it was only
introduced in 2014 (PROPHECY guidelines; Stryker). Our goal is to extend the
availability of TAR in all Dutch patients with end-stage osteoarthritis. We
hypothesize that PSI can give a (beginning) surgeon new to TAR an advantage
because PSI facilitates the complex TAR procedure.
Study objective
Primary Objective:
To compare the post-operative alignment accuracy of PSI PROPHECY*TAR between a
beginning (group A) and an experienced orthopedic surgeon (group B).
Secondary Objective:
To compare the operative time, complications, and patient-reported outcomes of
PSI PROPHECY*TAR between a beginning (group A) and an experienced orthopedic
surgeon (group B).
Study design
Single center cross-sectional observational study.
Study burden and risks
The risk of participation is limited to the standard risk of electromagnetic
radiation used for CT scanning without contrast fluids. By participating, a
participant will twice endure an additional effective dose (ED) of around 0.23
mSv, which corresponds with 14% of one year*s standard Dutch environmental dose
of radiation. The patient may in a few situations benefit from the additional
CT scan. If the patient is having complaints of the limb, the CT scan may
reveal a possible cause. If during the process novel asymptomatic abnormalities
or illnesses are suspected, the patient will be informed.
Wilhelminalaan 12
ALKMAAR 1815 JD
NL
Wilhelminalaan 12
ALKMAAR 1815 JD
NL
Listed location countries
Age
Inclusion criteria
- Patient can understand the study's meaning and is willing to sign the
study-specific Informed Patient Consent Form.
- Patient received the implantation of Infinity or Inbone prosthesis using
PROPHECY PSI for primary TAR in 2021-2023.
- There are at least 3 months of follow-up data for this patient.
- Patient can lay still during the length of duration of the CT-scan.
Exclusion criteria
- If per-operative the use of the PSI guides was abandoned.
- Patients that underwent revision surgery (defined as original tibia of talar
component change or removal).
- Patients that endured other diseases that significantly impacted the
post-operative period following TAR (e.g. amputation, severe extremity
dysfunction due to a neurological or vascular impairment or trauma).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83260.018.22 |