- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364604
Very Early Outcomes in Endoscopic Versus Open Carpal Tunnel Release
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 93405
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients 18 years of age or older, diagnosed with carpal tunnel syndrome and indicated to undergo carpal tunnel release with one of the three participating hand surgeons.
Carpal tunnel syndrome was diagnosed using the physical exam, including two-point discrimination, Phalen's test, Durkan's nerve compression test, and Tinel's sign in all study participants. All patients included in the study demonstrated a CTS-6 score over 12. An electromyography (EMG) of the median nerve was performed when determined to be necessary by either the treating surgeon or referring physician.
Description
Inclusion Criteria:
- Patients 18 years of age or older
- Diagnosed with carpal tunnel syndrome and indicated to undergo carpal tunnel release with one of the three participating hand surgeons were included in this study.
Exclusion Criteria:
- Patients younger than 18 years old
- Pregnant women
- Revision carpal tunnel surgery, or patients who underwent any other type of surgery concomitantly with the carpal tunnel release.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Endoscopic Carpal Tunnel Release
Patients who underwent endoscopic carpal tunnel release
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Description: An open incision was made over the proximal palm to access and visualize transverse carpal tunnel, then divided it completely surgically.
In the endoscopic technique, a small incision is made over the distal wrist and a camera and blade are within the wrist, then the transverse carpal ligament is divide from inside the palm
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Open Carpal Tunnel Release
Patients who underwent open carpal tunnel release
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Description: An open incision was made over the proximal palm to access and visualize transverse carpal tunnel, then divided it completely surgically.
In the endoscopic technique, a small incision is made over the distal wrist and a camera and blade are within the wrist, then the transverse carpal ligament is divide from inside the palm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative pain
Time Frame: This was assessed at post-operative days 3, 7, and 14
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This was evaluated by administering the Patient Related Wrist and Hand Evaluation (PRWHE) questionnaire as well as obtaining a pain score using the Visual Analog Scale (VAS).
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This was assessed at post-operative days 3, 7, and 14
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Function
Time Frame: Function was assessed at post-operative days 3, 7 and 14.
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Patients were first asked to assess the function of their operative hand and wrist using the Single Assessment Numeric Evaluation (SANE) tool.
Function was also assessed by administering the Patient Related Wrist and Hand Evaluation (PRWHE) questionnaire.
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Function was assessed at post-operative days 3, 7 and 14.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to Work Status
Time Frame: Return to work status was assessed at post-operative days 3, 7, and 14.
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Of those study patients who were not retired, we assessed if and when patients returned to work.
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Return to work status was assessed at post-operative days 3, 7, and 14.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Yao, MD, Stanford Department of Orthopedic Surgery
- Study Director: Robert J Reitz, MD, Stanford Department of Orthopedic Surgery
Publications and helpful links
General Publications
- Fajardo M, Kim SH, Szabo RM. Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg Am. 2012 Aug;37(8):1599-605. doi: 10.1016/j.jhsa.2012.04.035. Epub 2012 Jun 23.
- Ilyas AM, Miller AJ, Graham JG, Matzon JL. Pain Management After Carpal Tunnel Release Surgery: A Prospective Randomized Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone. J Hand Surg Am. 2018 Oct;43(10):913-919. doi: 10.1016/j.jhsa.2018.08.011.
- Chen L, Duan X, Huang X, Lv J, Peng K, Xiang Z. Effectiveness and safety of endoscopic versus open carpal tunnel decompression. Arch Orthop Trauma Surg. 2014 Apr;134(4):585-93. doi: 10.1007/s00402-013-1898-z. Epub 2014 Jan 12.
- Shin EK. Endoscopic Versus Open Carpal Tunnel Release. Curr Rev Musculoskelet Med. 2019 Dec;12(4):509-514. doi: 10.1007/s12178-019-09584-0.
- Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
- Graham B. The value added by electrodiagnostic testing in the diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2008 Dec;90(12):2587-93. doi: 10.2106/JBJS.G.01362.
- Sayegh ET, Strauch RJ. Open versus endoscopic carpal tunnel release: a meta-analysis of randomized controlled trials. Clin Orthop Relat Res. 2015 Mar;473(3):1120-32. doi: 10.1007/s11999-014-3835-z. Epub 2014 Aug 19.
- Mehta SP, MacDermid JC, Richardson J, MacIntyre NJ, Grewal R. A systematic review of the measurement properties of the patient-rated wrist evaluation. J Orthop Sports Phys Ther. 2015 Apr;45(4):289-98. doi: 10.2519/jospt.2015.5236.
- Gire JD, Koltsov JCB, Segovia NA, Kenney DE, Yao J, Ladd AL. Single Assessment Numeric Evaluation (SANE) in Hand Surgery: Does a One-Question Outcome Instrument Compare Favorably? J Hand Surg Am. 2020 Jul;45(7):589-596. doi: 10.1016/j.jhsa.2020.03.024. Epub 2020 May 29.
- Kishan A, Kubsad S, Haft M, Fox HM, Tuffaha SH, LaPorte DM, Nguyen DM. Endoscopic Versus Open Treatment of Carpal Tunnel Syndrome: Postoperative Complications in Patients With Diabetes Mellitus. J Hand Surg Glob Online. 2024 Jun 12;6(4):577-582. doi: 10.1016/j.jhsg.2024.04.015. eCollection 2024 Jul.
- Li Y, Luo W, Wu G, Cui S, Zhang Z, Gu X. Open versus endoscopic carpal tunnel release: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2020 Apr 27;21(1):272. doi: 10.1186/s12891-020-03306-1.
- Saw NL, Jones S, Shepstone L, Meyer M, Chapman PG, Logan AM. Early outcome and cost-effectiveness of endoscopic versus open carpal tunnel release: a randomized prospective trial. J Hand Surg Br. 2003 Oct;28(5):444-9. doi: 10.1016/s0266-7681(03)00097-4.
- Aslani HR, Alizadeh K, Eajazi A, Karimi A, Karimi MH, Zaferani Z, Hosseini Khameneh SM. Comparison of carpal tunnel release with three different techniques. Clin Neurol Neurosurg. 2012 Sep;114(7):965-8. doi: 10.1016/j.clineuro.2012.02.017. Epub 2012 Mar 14.
- Miles MR, Shetty PN, Bhayana K, Yousaf IS, Sanghavi KK, Giladi AM. Early Outcomes of Endoscopic Versus Open Carpal Tunnel Release. J Hand Surg Am. 2021 Oct;46(10):868-876. doi: 10.1016/j.jhsa.2021.04.030. Epub 2021 May 25.
- Macdermid JC, Richards RS, Roth JH, Ross DC, King GJ. Endoscopic versus open carpal tunnel release: a randomized trial. J Hand Surg Am. 2003 May;28(3):475-80. doi: 10.1053/jhsu.2003.50080.
- Agee JM, McCarroll HR Jr, Tortosa RD, Berry DA, Szabo RM, Peimer CA. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg Am. 1992 Nov;17(6):987-95. doi: 10.1016/s0363-5023(09)91044-9.
- Williamson ERC, Vasquez Montes D, Melamed E. Multistate Comparison of Cost, Trends, and Complications in Open Versus Endoscopic Carpal Tunnel Release. Hand (N Y). 2021 Jan;16(1):25-31. doi: 10.1177/1558944719837020. Epub 2019 Mar 29.
- Barnes JI, Paci G, Zhuang T, Baker LC, Asch SM, Kamal RN. Cost-Effectiveness of Open Versus Endoscopic Carpal Tunnel Release. J Bone Joint Surg Am. 2021 Feb 17;103(4):343-355. doi: 10.2106/JBJS.19.01354.
- Vasiliadis HS, Georgoulas P, Shrier I, Salanti G, Scholten RJ. Endoscopic release for carpal tunnel syndrome. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD008265. doi: 10.1002/14651858.CD008265.pub2.
- Trumble TE, Diao E, Abrams RA, Gilbert-Anderson MM. Single-portal endoscopic carpal tunnel release compared with open release : a prospective, randomized trial. J Bone Joint Surg Am. 2002 Jul;84(7):1107-15. doi: 10.2106/00004623-200207000-00003.
- Okutsu I, Ninomiya S, Takatori Y, Ugawa Y. Endoscopic management of carpal tunnel syndrome. Arthroscopy. 1989;5(1):11-8. doi: 10.1016/0749-8063(89)90084-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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