Total Ankle Replacement Using Guides, Expert Versus Trainee

Status: Not_yet_recruiting
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Time Frame
Start Date: 2024-04
Completion Date: 2025-12
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Centre for Orthopaedic Research Alkmaar
Collaborators: Noordwest Ziekenhuisgroep

This content was sourced from clinicaltrials.gov