Patient Specific Instrumentation in ACL Reconstruction

NCT05574452 | Unknown

• 1 other identifier: 201400122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Patient specific instrumentation; ACL reconstruction; Femoral tunnel position

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Deviation in mm of realised femoral tunnel position compared to planned femoral tunnel position. Measured on pre and postoperative MRI

  2 weeks post surgery

Secondary Outcomes (1)

• Complications

  2 weeks post surgery

Study Arms (1)

Pilot group

EXPERIMENTAL

Pilot group undergoing ACL reconstruction using the SONAR Femoral Aimer PSI

Device: ACL reconstruction using the SONAR Femoral Aimer PSI

Interventions

ACL reconstruction using the SONAR Femoral Aimer PSI DEVICE

ACL reconstruction using the SONAR Femoral Aimer PSI

Pilot group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>16 years
• Primary ACL injury requiring ACL reconstruction

You may not qualify if:

• No preoperative MRI available.
• Inability to understand the Dutch language (assessed by the treating physician)

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Ommelander Ziekenhuis Groningen: collaborator

Study Sites (2)

Ommelander Ziekenhuis Groningen

Scheemda, Provincie Groningen, 9679BJ, Netherlands

Location

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Mark Zee, MD

CONTACT

+31503616161; m.j.m.zee@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Study

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

NL (2)