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Search / Trial NCT05729958

Total Ankle Replacement Using Guides, Expert Versus Trainee

Launched by CENTRE FOR ORTHOPAEDIC RESEARCH ALKMAAR · Feb 14, 2023

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Arthroplasty Patient Specific Instrumentation

ClinConnect Summary

This clinical trial is studying a new approach to ankle replacement surgery for patients with ankle osteoarthritis, a condition that causes pain and stiffness in the ankle joint. The researchers want to compare the outcomes of surgeries performed by both experienced and beginner surgeons using a special tool called Patient Specific Instrumentation (PSI). This tool is designed to help surgeons perform the complex procedure more accurately and quickly, which could potentially make it easier for new surgeons to learn the technique and help more patients in the future.

To be eligible for this trial, participants should be between the ages of 65 and 87, have had an ankle replacement surgery using specific prosthetic devices in 2022, and have at least three months of follow-up data. They must also be able to understand the study and agree to participate. Those who might not qualify include patients who had complications during surgery or other significant health issues that could affect their recovery. Participants will be monitored for surgery outcomes, including how long the surgery takes, any complications, and their recovery experience. Overall, this trial aims to improve the way ankle replacements are performed and make the surgery safer for new surgeons and patients alike.

Gender

ALL

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).

About Centre For Orthopaedic Research Alkmaar

The Centre for Orthopaedic Research Alkmaar is a leading clinical trial sponsor dedicated to advancing the field of orthopaedics through innovative research and development. With a multidisciplinary team of experts, the center focuses on conducting high-quality clinical trials that aim to improve patient outcomes and enhance surgical techniques. By fostering collaboration between clinicians, researchers, and industry partners, the Centre for Orthopaedic Research Alkmaar is committed to translating scientific discoveries into practical applications, ensuring the highest standards of safety and efficacy in orthopaedic treatments.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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