Total Ankle Replacement using Guides, Expert versus Trainee

Recruiting

Conditions: joint wear
Osteoarthritis
10023213

Registration Number: NL-OMON56252

Lead Sponsor: oordwest Ziekenhuisgroep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in TAR component accuracy between the preoperative and 2-year<br /><br>postoperative model based on CT scans.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Abandonment of PSI per-operative, percentage of accurately aligned components,<br /><br>percentage of accurately predicted implant size (both talar rand tibia<br /><br>components), patient-reported outcome measures (PROM), and complication and<br /><br>revision rate.</p><br>