Scapholunate Dissociation Clinical Trial
— CanRASLOfficial title:
Evaluation of the Surgical Proficiency and Effectiveness of the Acumed(R) Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Calgary | Acumed, LLC |
Geissler WB. Arthroscopically assisted reduction of intra-articular fractures of the distal radius. Hand Clin. 1995 Feb;11(1):19-29. — View 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. — View 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. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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). | 2 years | |
Secondary | 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. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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