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

Primary Purpose

Complete Tear of Scapholunate Ligament, Scapholunate Dissociation

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ACUMED® Scapholunate Repair System Group
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Tear of Scapholunate Ligament focused on measuring Scapholunate interosseous ligament, Reduction and association of the scaphoid and lunate, RASL, Acumed Scapholunate Repair System

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has primary, chronic (> 6 weeks) scapholunate instability diagnosed by X-ray, dynamic X-ray, MRI/MRI arthrogram and/or arthroscopy
  • Subject is a suitable candidate for RASL repair with the ACUMED® Scapholunate Repair System
  • Subject is willing and able to participate in required follow-up visits and can complete study activities.
  • Subject provides informed consent

Exclusion Criteria:

  • Subject has scapholunate advanced collapse wrist arthritis above grade I (styloid only)
  • Subject has conditions that would eliminate or tend to eliminate adequate implant support:

    1. Blood supply limitations;
    2. Insufficient quantity or quality of bone support (osteoporosis, metabolic disorders which may impair bone formation, tumor, osteomalacia, etc.).
  • Subject has mental or neurological conditions which impair their ability or willingness to restrict activities that may put the affected limb at risk.
  • Subject has physical conditions that tend to place extreme loads on the implants (Charcot joints, muscle deficiencies etc.).
  • Subject has neuromuscular dysfunctions (paralysis, myolysis, etc.) which could cause instability of the wrist after surgery
  • Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  • Subject has an active infection - systemic or at the site of intended surgery
  • Subject has a known allergy to any component of the devices used in the study
  • Subject is pregnant or breast feeding
  • Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ACUMED® Scapholunate Repair System

    Arm Description

    All participants in this trial will undergo the surgical RASL procedure using the ACUMED® Scapholunate Repair System.

    Outcomes

    Primary Outcome Measures

    Assess surgical proficiencies and effectiveness with the ACUMED® Scapholunate Repair System
    Surgeons will complete a standardized proprietary questionnaire at the start of the study and on a case by case basis following each surgical procedure (Post-operatively). The goal is to measure and track the level of surgeon comfort and proficiency with the ACUMED® Scapholunate Repair System. Surgical time, tourniquet time and fluoroscopy time will be used a surrogate measures of surgical proficiency.
    Quality of Screw Placement
    Scapholunate screw trajectory will be validated and graded based on screw angle (ideally 23 degrees), position in the ulnar vertex (proximal ulnar corner), and sagittal alignment (middle third of scaphoid) based on intra-operative or immediate post-operative AP and lateral X-rays.

    Secondary Outcome Measures

    Correlate Clinical Outcomes to Reduction and Screw Trajectory
    Functional outcomes will be assessed using the Patient-Rated Wrist Evaluation (PRWE), Disabilities of the Arm, Shoulder and Hand (DASH), PROMIS Upper Extremity, and Visual Analogue Pain Scale (VAS).
    Report Safety Complications and Adverse Events
    Complications, adverse events and serious adverse events possibly related, probably related, or related to the device and/or the surgical procedure that may adversely affect study functional outcome scores will be recorded.

    Full Information

    First Posted
    July 15, 2021
    Last Updated
    May 16, 2022
    Sponsor
    University of Calgary
    Collaborators
    Acumed, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04980547
    Brief Title
    Evaluation of the Surgical Proficiency and Effectiveness of the Acumed Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
    Acronym
    CanRASL
    Official Title
    Evaluation of the Surgical Proficiency and Effectiveness of the Acumed(R) Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Calgary
    Collaborators
    Acumed, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    The scapholunate interosseous ligament (SLIL) of the wrist can be likened to the ACL of the knee as an often-injured ligament causing joint instability that frequently impairs function and requires surgical reconstruction. Yet wrist surgeons are significantly behind knee surgeons in their ability to achieve consistent and reliable outcomes with surgical reconstruction of this ligament. This ligament is often treated using a surgical procedure of reduction and association of scaphoid and lunate (RASL). However, this procedure is accompanied with technical challenges regarding proper screw placement and trajectory. The ACUMED® Scapholunate Repair System presents as a novel and innovated device that has the potential to improve surgeon proficiency with the RASL procedure. The purpose of this trial is to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction. The study will assess the surgeon learning curve with the ACUMED® Scapholunate Repair System, record safety, complications, outcomes and adverse events for 2 years after surgery. This study will generate clinical evidence to support and maintain product registration in global markets. Patients presenting with sub-acute or chronic (>8 weeks) primary SLIL instability that will be treated surgically at up to 20 study sites across Canada. A total of 50 wrists will be enrolled into the study and surgeons will utilize the ACUMED® Scapholunate Repair System during the surgical procedure. The study is expected to enroll all subjects within a 2-year time frame, and patients will be followed for 2 years after surgery. Subjects for whom the informed consent process has been completed and have been implanted with the study product will be considered enrolled. At baseline, research staff will obtain data regarding participant demographics, injury characteristics, and medical history. Pre-operatively, participants will also be assessed for range of motion and grip strength and will have completed radiographs and three wrist function questionnaires, the DASH, the PRWE, and the PROMIS. Surgeons will answer questionnaires at the start of the study, after each surgical case, and at the end of the study to provide an assessment of the repair system's utility. The quality of screw placement will be graded on a newly created scale (from retrospective chart review of prior RASL procedures) to measure screw trajectory and final placement. Participants will have follow standard of care follow up timeline with preoperative visits at 2-, 8-, 12, 24- weeks, 1 year, 18 months, and 2 years. At each follow up visit, range of motion data, grip strength (after 24 weeks), and questionnaires will be completed. Data will be reported as numbers and percentages of total for categorical data, and as mean and standard deviation of the mean with 95% confidence intervals for continuous variables. Ordinal data from the Likert scale surgeon questionnaire and screw placement grading scales will also be analyzed using parametric statistics (1, 2). Total scores from the scale items will be analyzed using the Kappa statistics. Independent sample t-tests will be used to compare the mean DASH, PRWE and PROMIS scores and for time to return to work, school, and sports. For secondary analysis, an analysis of variance will be completed for the DASH, PRWE and PROMIS scores, range of motion data and grip strength at each follow-up time interval.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complete Tear of Scapholunate Ligament, Scapholunate Dissociation
    Keywords
    Scapholunate interosseous ligament, Reduction and association of the scaphoid and lunate, RASL, Acumed Scapholunate Repair System

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a prospective, multi-centre, non-randomized, and non-blinded follow-up study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ACUMED® Scapholunate Repair System
    Arm Type
    Experimental
    Arm Description
    All participants in this trial will undergo the surgical RASL procedure using the ACUMED® Scapholunate Repair System.
    Intervention Type
    Device
    Intervention Name(s)
    ACUMED® Scapholunate Repair System Group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Assess surgical proficiencies and effectiveness with the ACUMED® Scapholunate Repair System
    Description
    Surgeons will complete a standardized proprietary questionnaire at the start of the study and on a case by case basis following each surgical procedure (Post-operatively). The goal is to measure and track the level of surgeon comfort and proficiency with the ACUMED® Scapholunate Repair System. Surgical time, tourniquet time and fluoroscopy time will be used a surrogate measures of surgical proficiency.
    Time Frame
    Immediately after surgery
    Title
    Quality of Screw Placement
    Description
    Scapholunate screw trajectory will be validated and graded based on screw angle (ideally 23 degrees), position in the ulnar vertex (proximal ulnar corner), and sagittal alignment (middle third of scaphoid) based on intra-operative or immediate post-operative AP and lateral X-rays.
    Time Frame
    Immediately after surgery
    Secondary Outcome Measure Information:
    Title
    Correlate Clinical Outcomes to Reduction and Screw Trajectory
    Description
    Functional outcomes will be assessed using the Patient-Rated Wrist Evaluation (PRWE), Disabilities of the Arm, Shoulder and Hand (DASH), PROMIS Upper Extremity, and Visual Analogue Pain Scale (VAS).
    Time Frame
    2 years
    Title
    Report Safety Complications and Adverse Events
    Description
    Complications, adverse events and serious adverse events possibly related, probably related, or related to the device and/or the surgical procedure that may adversely affect study functional outcome scores will be recorded.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject has primary, chronic (> 6 weeks) scapholunate instability diagnosed by X-ray, dynamic X-ray, MRI/MRI arthrogram and/or arthroscopy Subject is a suitable candidate for RASL repair with the ACUMED® Scapholunate Repair System Subject is willing and able to participate in required follow-up visits and can complete study activities. Subject provides informed consent Exclusion Criteria: Subject has scapholunate advanced collapse wrist arthritis above grade I (styloid only) Subject has conditions that would eliminate or tend to eliminate adequate implant support: Blood supply limitations; Insufficient quantity or quality of bone support (osteoporosis, metabolic disorders which may impair bone formation, tumor, osteomalacia, etc.). Subject has mental or neurological conditions which impair their ability or willingness to restrict activities that may put the affected limb at risk. Subject has physical conditions that tend to place extreme loads on the implants (Charcot joints, muscle deficiencies etc.). Subject has neuromuscular dysfunctions (paralysis, myolysis, etc.) which could cause instability of the wrist after surgery Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject has an active infection - systemic or at the site of intended surgery Subject has a known allergy to any component of the devices used in the study Subject is pregnant or breast feeding Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brenna Mattiello, BKin
    Phone
    (403)9563687
    Email
    brenna.mattiello1@ucalgary.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catherine Leonard, M.Sc.
    Phone
    (403)8522035
    Email
    cleonard@ucalgary.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neil J White, MD
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7751327
    Citation
    Geissler WB. Arthroscopically assisted reduction of intra-articular fractures of the distal radius. Hand Clin. 1995 Feb;11(1):19-29.
    Results Reference
    background
    PubMed Identifier
    24436801
    Citation
    Messina JC, Van Overstraeten L, Luchetti R, Fairplay T, Mathoulin CL. The EWAS Classification of Scapholunate Tears: An Anatomical Arthroscopic Study. J Wrist Surg. 2013 May;2(2):105-9. doi: 10.1055/s-0033-1345265.
    Results Reference
    background
    PubMed Identifier
    30900438
    Citation
    Montgomery SJ, Rollick NJ, Kubik JF, Meldrum AR, White NJ. Surgical outcomes of chronic isolated scapholunate interosseous ligament injuries: a systematic review of 805 wrists. Can J Surg. 2019 Mar 22;62(3):1-12. doi: 10.1503/cjs.006918. Online ahead of print.
    Results Reference
    background
    Links:
    URL
    http://www.scrubsresearch.com/
    Description
    SCRUBS Research Group

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

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