Prospective, Monocenter, Non-randomized Clinical Investigation Evaluating the Safety, Clinical Performance and Effectiveness of Sono-instruments for the Percutaneous Ultrasound-guided Treatment of Carpal Tunnel Syndrome and Trigger Finger
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trigger Finger
- Sponsor
- Spirecut
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Safety of percutaneous surgery performed with Sono-Instuments
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Carpal Tunnel (CT) syndrome is a collection of characteristic symptoms and signs that occurs following compression of the median nerve within the CT. In Trigger Finger / trigger thumb (TF), one of the most common causes of hand pain and disability, the flexor tendon causes painful popping or snapping as the patient flexes and extends the digit. In case of failure of non-operative treatments, patients with CT syndrome or TF are operated. Clearly any improvement in surgical device design would be of great advantage to the patient and the surgeon. Spirecut's single use, pre-CE Sono-Instruments (SI) allow the percutaneous treatment of Carpal Tunnel (CT)syndrome and Trigger Finger/thumb (TF) under sonography (instead of open or endoscopic approach). Two models will be assessed in this clinical investigation:
- The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament.
- The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley.
Using those SI, surgical procedures can be performed without endangering adjacent structures (e.g. median nerve and branches, ulnar pedicle, superficial carpal arch, digital pedicles, flexor tendons).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults ≥ 18 years of age;
- •Primary CT confirmed by typical symptoms, signs and altered nerve conduction studies;
- •Pain and/or numbness in the hand which worsen at night (or are present only at night);
- •Participant and investigator signed and dated the Informed Consent Form (ICF) prior to the index-procedure.
- •Participants with Trigger Finger/thumb:
- •Inclusion Criteria:
- •Adults ≥ 18 years of age;
- •Typical signs and symptoms of TF/thumb caused by friction or blockade of flexor tendon(s) in digital sheath, without flexion contracture over 30° of the proximal interphalangeal (or interphalangeal for the thumb) joint, confirmed by altered flexor tendon(s) gliding and/or increased thickness of A1 digital pulley under sonography (sonography can be done just before the operation, that is after signature of the ICF);
- •Participant and investigator signed and dated the ICF prior to the index-procedure.
- •Exclusion criteria:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety of percutaneous surgery performed with Sono-Instuments
Time Frame: 6 weeks after the procedure
Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.
Secondary Outcomes
- Performance of Sono-Instruments during percutaneous surgery(During the index procedure)
- Pre-operative pain(During screening)
- Clinical effectiveness of percutaneous surgery performed with Sono-Instruments(6 weeks after the procedure)
- Post-operative pain of percutaneous surgery performed with Sono-Instruments(6 weeks after the procedure)