Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments

Study 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).

Official Title
-----------------
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

Conditions
-----------------
Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Device: Sono-Intruments


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants with Carpal tunnel syndrome: 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: Participants with one or more of the following conditions are excluded from the study: Dwarfism or participants with small size hand/CT/TF-thumb; Past or active infection; Known allergic reaction to metals; Coagulation problems, with significant risk of per/postoperative bleeding; In case of TF: long evolution, with ankylosis of the proximal interphalangeal joint; In case of CT: severe median nerve dysfunction; Previous facture or dislocation in the operated area or any affection causing malalignment or distortion of the local skeleton due to trauma, arthritis or other causes; Other known clinical risks outweighing the expected clinical benefits or increasing the risk of a postoperative lesion (e.g. tissue adhesions, anatomical abnormalities, neuro-vascular structures in the zone of the intended release, local tumors); Insufficient sonographic identification of the operated tissue; Previous attempt to treat the condition; Currently receiving treatment for CT or TF; Contra-indication to local anesthesia (general, regional or local); Participant unable (vulnerable participant)/unwilling to provide informed consent; Participant is enrolled in another study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb<br> | Device: Sono-Intruments<br>* 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: 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of percutaneous surgery performed with Sono-Instuments | Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions. | During the index procedure | 
| Safety of percutaneous surgery performed with Sono-Instuments | Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions. | Within 1 week after the procedure | 
| Safety of percutaneous surgery performed with Sono-Instuments | Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions. | 6 weeks after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Sono-Instruments during percutaneous surgery | Ease of positioning of Sono-Instruments during percutaneous surgery. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. | During the index procedure | 
| Performance of Sono-Instruments during percutaneous surgery | Maneuverability of Sono-Instruments during percutaneous surgery. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. | During the index procedure | 
| Performance of Sono-Instruments during percutaneous surgery | Visibility (location and orientation) of the Sono-Instruments under sonography. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. | During the index procedure | 
| Performance of Sono-Instruments during percutaneous surgery | Technical success of the surgical procedure, defined as percutaneous surgery as intended without technical difficulties and without conversion to another surgical intervention. | During the index procedure | 
| Pre-operative pain | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | During screening | 
| Post-operative pain of percutaneous surgery performed with Sono-Instruments | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | Within 1 week after the procedure | 
| Post-operative pain of percutaneous surgery performed with Sono-Instruments | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medications. | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with carpal tunnel syndrome. | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | During screening | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medication. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medication. | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Post-operative time to return to activities of daily living as prescribed by the doctor and effectively done by participant. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Post-operative time to return to work as prescribed by the doctor and effective return to work for participants that are employed. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Number of days between surgery and washing of the operated hand for the first time. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome. | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of pillar pain in patients with Carpal Tunnel Syndrome. | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of pillar pain in patients with Carpal Tunnel Syndrome. | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | 6 weeks after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Modified Patel and Bassini's grading system in patients with trigger finger/thumb, including 2 items with 4 response options each (1 = no improvement, 4 = full improvement). | Within 1 week after the procedure | 
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Modified Patel and Bassini's grading system in patients with trigger finger/thumb, including 2 items with 4 response options each (1 = no improvement, 4 = full improvement). | 6 weeks after the procedure |