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Not Yet Recruiting NCT05729958

Post-operative Accuracy of Patient-Specific Instrumentation in Total Ankle Arthroplasty

Conditions: Ankle Osteoarthritis

Sex: All
Ages: 18 Years – 90 Years
Enrollment: 20
Sponsor: Centre for Orthopaedic Research Alkmaar

Summary

Patient Specific Instrumentation (PSI) is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment. Studies about the learning curve of PSI for total ankle replacement (TAR) are lacking because it was only introduced in 2014.The investigators believe that PSI could give a beginning ankle surgeon, or surgeons new to TAR, an advantage since PSI facilitates the complex TAR procedure. As such, the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended. To estimate this potential of PSI for TAR, the investigators aim (1) to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon, and (2) to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time, complications, and patient-reported outcomes with those of an experienced specialist.

Eligibility 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 2022.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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05729958). StuddyBuddy aggregates publicly available trial information.