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Evaluation of the Surgical Proficiency and Effectiveness of the Acumed Scapholunate Repair System in Primary Scapholunate Instability Among Canadians

NCT04980547 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-18

No results posted yet for this study

Summary

This study is a prospective, multi-centre, non-randomized, and non-blinded follow-up study to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction.

Conditions

  • Complete Tear of Scapholunate Ligament
  • Scapholunate Dissociation

Interventions

DEVICE

ACUMED® Scapholunate Repair System Group

To address the technical difficulties associated with the RASL procedure, Dr. Mel Rosenwasser developed an external over-the-top jig that in theory enables accurate and easy scapholunate-axis screw placement. The Acumed Scapholunate Repair System was designed treat patients with acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability. This new Scapholunate Repair System features a targeting guide designed to enable the surgeon to reproducibly place the implant in optimal position. The implant allows physiologic intercarpal scapholunate rotation by means of a free rotation design. The procedure can forestall progressive osteoarthritis and the need for secondary salvage procedures.

Sponsors & Collaborators

  • Acumed, LLC

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Neil J White, MD · University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

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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 NCT04980547 on ClinicalTrials.gov