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Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments (SONO-01)

Primary Purpose

Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sono-Intruments
Sponsored by
Spirecut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasme University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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").
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").
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").
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medications.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document what the participant cannot do with his/her affected hand.
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).
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).
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).
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of numbness/pain at night in patients with carpal tunnel syndrome.
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).
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document what the participant cannot do with his/her affected hand.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document what the participant cannot do with his/her affected hand.
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).
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).
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.
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.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Number of days between surgery and washing of the operated hand for the first time.
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).
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).
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).
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).
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
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).
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).
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).
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).

Full Information

First Posted
June 9, 2022
Last Updated
May 17, 2023
Sponsor
Spirecut
Collaborators
Archer Research
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1. Study Identification

Unique Protocol Identification Number
NCT05435950
Brief Title
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
Acronym
SONO-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirecut
Collaborators
Archer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sono-Intruments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of percutaneous surgery performed with Sono-Instuments
Description
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
Title
Safety of percutaneous surgery performed with Sono-Instuments
Description
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
Title
Safety of percutaneous surgery performed with Sono-Instuments
Description
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
Secondary Outcome Measure Information:
Title
Performance of Sono-Instruments during percutaneous surgery
Description
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
Title
Performance of Sono-Instruments during percutaneous surgery
Description
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
Title
Performance of Sono-Instruments during percutaneous surgery
Description
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
Title
Performance of Sono-Instruments during percutaneous surgery
Description
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
Title
Pre-operative pain
Description
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
Title
Post-operative pain of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Post-operative pain of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document use of anti-inflammatory/pain medications.
Time Frame
During screening
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document what the participant cannot do with his/her affected hand.
Time Frame
During screening
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Noting of numbness/pain at night in patients with carpal tunnel syndrome.
Time Frame
During screening
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document use of anti-inflammatory/pain medication.
Time Frame
Within 1 week after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document use of anti-inflammatory/pain medication.
Time Frame
6 weeks after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document what the participant cannot do with his/her affected hand.
Time Frame
Within 1 week after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Document what the participant cannot do with his/her affected hand.
Time Frame
6 weeks after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Number of days between surgery and washing of the operated hand for the first time.
Time Frame
Within 1 week after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome.
Time Frame
Within 1 week after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome.
Time Frame
6 weeks after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
Time Frame
Within 1 week after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
Time Frame
6 weeks after the procedure
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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
Title
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Erasme University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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