MedTrace Logo

Patient Specific Instrumentation in ACL Reconstruction

NCT05574452 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-12

No results posted yet for this study

Summary

Rationale: In anterior cruciate ligament (ACL) reconstruction, anatomical femoral tunnel positioning has proven to be difficult with current techniques. Limited visibility during surgery and high interpersonal variability are mainly responsible for non-anatomical femoral tunnel positioning. Non anatomical tunnel positioning can lead to long term failure of the reconstruction. In order to obtain an accurate and constant anatomical femoral tunnel position during ACL reconstruction, a patient specific surgical guide has been developed.

Objective: to assess the accuracy of the newly developed patient specific femoral aimer used during ACL reconstruction.

Study design: pilot study

Study population: 10 subjects (\>16 years of age ) with ACL injury, requiring ACL reconstruction.

Intervention: all subjects will undergo ACL reconstruction in which a patient specific surgical guide is used for femoral tunnel positioning.

Main study parameters/endpoints: the main study parameter is the difference between the planned femoral tunnel position and the achieved tunnel position. This difference is quantified in both mm (translation) and degrees (rotation).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional perioperative risks are associated with participation. Based on previous cadaver experiments, the accuracy of the patient specific, 3D printed femoral aimer is high. Subjects will undergo 1 postoperative MRI which will take place during a routine scheduled follow up visit.

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

DEVICE

ACL reconstruction using the SONAR Femoral Aimer PSI

ACL reconstruction using the SONAR Femoral Aimer PSI

Sponsors & Collaborators

  • Ommelander Ziekenhuis Groningen

    collaborator UNKNOWN

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574452 on ClinicalTrials.gov