An interventional study of Sono-Intruments in Trigger Finger, Trigger Thumb and Carpal Tunnel Syndrome, sponsored by Spirecut. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Spirecut · Not applicable, Interventional, and Treatment
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:
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).
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →This is the only study on the registry with Spirecut as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants with Carpal tunnel syndrome:
Inclusion Criteria:
Participants with Trigger Finger/thumb:
Inclusion Criteria:
Exclusion criteria:
Participants with one or more of the following conditions are excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Sono-Intruments
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks after the procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medications.
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document what the participant cannot do with his/her affected hand.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of numbness/pain at night in patients with carpal tunnel syndrome.
Time frame: 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).
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 weeks after the procedure
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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