Total Ankle Replacement Using Guides, Expert Versus Trainee

NCT05729958 | Not Yet Recruiting DMC

• 1 other identifier: NL83260.018.22
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ankle Osteoarthritis

Keywords

Arthroplasty; Patient-specific Instrumentation

Outcome Measures

Primary Outcomes (1)

• Postoperative TAR component accuracy

  Difference between the planned and obtained (anterior and sagittal) tibia angles.

  2-year follow-up assessment

Secondary Outcomes (3)

• Foot and Ankle Outcome Score (FAOS)

  2-year follow-up assessment

• Foot Function Index (FFI)

  2-year follow-up assessment

• American Orthopedic Foot and Ankle Score (AOFAS)

  2-year follow-up assessment

Other Outcomes (1)

• Complications

  2-year follow-up

Interventions

CT scan DIAGNOSTIC_TEST

CT scan of the involved ankle

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that received primary TAR pre-operatively planned using PROPHECY PSI in 2022. Both traumatic and non-traumatic osteoarthritis are included.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre for Orthopaedic Research Alkmaar: lead
• Noordwest Ziekenhuisgroep: collaborator

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 15, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02