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Total Ankle Replacement using Guides, Expert versus Trainee

Total Ankle Replacement using Guides, Expert versus Trainee - TARGET

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56252
Enrollment
15
Registered
2023-06-07
Start date
2024-05-29
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

joint wear Osteoarthritis

Interventions

None listed

Sponsors

Noordwest Ziekenhuisgroep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The difference in TAR component accuracy between the preoperative and 2-year postoperative model based on CT scans.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)