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

NCT04980547 | Unknown Phase 1 FDA Device

• 1 other identifier: REB20-2245
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complete Tear of Scapholunate Ligament; Scapholunate Dissociation

Keywords

Scapholunate interosseous ligament; Reduction and association of the scaphoid and lunate; RASL; Acumed Scapholunate Repair System

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately after surgery

• 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.

  Immediately after surgery

Secondary Outcomes (2)

• Correlate Clinical Outcomes to Reduction and Screw Trajectory

  2 years

• Report Safety Complications and Adverse Events

  2 years

Study Arms (1)

ACUMED® Scapholunate Repair System

EXPERIMENTAL

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

Device: ACUMED® Scapholunate Repair System Group

Interventions

ACUMED® Scapholunate Repair System Group DEVICE

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.

ACUMED® Scapholunate Repair System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Acumed, LLC: collaborator

Related Publications (3)

• Geissler WB. Arthroscopically assisted reduction of intra-articular fractures of the distal radius. Hand Clin. 1995 Feb;11(1):19-29.

  PMID: 7751327 BACKGROUND

• 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.

  PMID: 24436801 BACKGROUND

• 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.

  PMID: 30900438 BACKGROUND

Related Links

• SCRUBS Research Group

Study Officials

• Neil J White, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenna Mattiello, BKin

CONTACT

(403)9563687; brenna.mattiello1@ucalgary.ca

Catherine Leonard, M.Sc.

CONTACT

(403)8522035; cleonard@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Section of Orthopaedics, Hand & Wrist Surgeon, University of Calgary

Model Details: This is a prospective, multi-centre, non-randomized, and non-blinded follow-up study.

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 28, 2021
• Study Start: January 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share