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Sponsor changing database systems for ease of use for patient data collection
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The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SX-One MicroKnife with ultrasound guidance | Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance |
| |
| Traditional mini-open technique without ultrasound guidance | Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carpal Tunnel Release | Device | Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function. | 12 months |
| Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported time to return to activities | Patient reported time to return to normal activities as measured in days. | Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported satisfaction following carpal tunnel release | Patient reported satisfaction with the carpal tunnel release procedure on a 1-5 scale with higher numbers indicating greater satisfaction. | 2 weeks, 1,3,6 and 12 months |
| Patient reported symptom improvement following carpal tunnel release |
Inclusion Criteria:
Exclusion Criteria:
• Age less than 18 years
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Patients scheduled to undergo carpal tunnel release surgery using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Smith, MD | Sonex Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonex Health, Inc. | Eagan | Minnesota | 55121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32876476 | Background | Kamel SI, Freid B, Pomeranz C, Halpern EJ, Nazarian LN. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2. | |
| 31659789 | Background | Chappell CD, Beckman JP, Baird BC, Takke AV. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693-702. doi: 10.1002/jum.15146. Epub 2019 Oct 29. |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Carpal Tunnel Release | Procedure | Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance. |
|
Patient reported improvement in symptoms following carpal tunnel release, reported on a 1-5 scale with higher numbers indicating more symptom improvement. |
| 2 weeks, 1,3,6 and 12 months |
| Pain reported pain on numerical pain rating scale | Patient reported pain following carpal tunnel release, reported on an 11-point (0-10) numerical pain rating scale with higher numbers indicating more pain. | Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months |
| 31449326 | Background | Joseph AE, Leiby BM, Beckman JP. Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. J Ultrasound Med. 2020 Mar;39(3):441-452. doi: 10.1002/jum.15120. Epub 2019 Aug 26. |
| 29608024 | Background | Henning PT, Yang L, Awan T, Lueders D, Pourcho AM. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results. J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2. |
| 29518589 | Background | Latzka EW, Henning PT, Pourcho AM. Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. PM R. 2018 Oct;10(10):1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6. |
| 29518587 | Background | Henning T, Lueders D, Chang K, Yang L. Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report. PM R. 2018 Oct;10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016. Epub 2018 Mar 6. |
| 33511873 | Background | Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 29. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |