Carpal Tunnel SyndromeSTCCOTNCT05468814
Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome
A study testing Z-plasty and Conventional in people with Carpal Tunnel Syndrome, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Z-plasty and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2022to 28 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Moderate-severe carpal tunnel syndrome
- Symptoms that hinder the patient's daily activities
- Correct conservative treatment without success
Who cannot join
- Previous surgical intervention for carpal tunnel syndrome
- Traumatic or congenital sequelae of the hand
- Incompetence to understand the process and the tests to be carried out
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial
The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.
Read the detailed description
It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied.
The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate" or "severe". As inclusion criteria, patients >18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded.
The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires.
The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Z-plasty, Conventional
- Keywords
- Carpal Tunnel Syndrome, Pillar pain, Grip strength, Pincer strength
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-plastyProcedure or surgery
It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.
ConventionalProcedure or surgery
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
| Study group | Role | What they receive |
|---|---|---|
| Z-plasty | Experimental | It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch. Receives: Procedure: Z-plasty |
| Conventional | Active comparator | It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pillar Pain
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
Measured: 3 weeks after surgery
Incidence of Pillar Pain
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
Measured: 6 months after surgery
Secondary outcomes (8)
Grip Strength
Grip strength measured with a dynamometer
Measured: 3 weeks after surgery
Grip Strength
Grip strength measured with a dynamometer
Measured: 6 months
Pinch Strength
Pinch strength measured with a dynamometer
Measured: 3 weeks
Pinch Strength
Pinch strength measured with a dynamometer
Measured: 6 months
Clinical BCTQ
Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.
Minimum: 1 (better). Maximum: 5 (worse)
Measured: 3 weeks after surgery
Functional BCTQ
Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.
Minimum: 1 (better). Maximum: 5 (worse)
Measured: 6 months
Clinical BCTQ
Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome.
Minimum: 1 (better). Maximum: 5 (worse)
Measured: 6 months
Functional BCTQ
Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome.
Minimum: 1 (better). Maximum: 5 (worse)
Measured: 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start18 Jul 2022
- Primary completion28 Apr 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Irene Calzado Álvarez de Lara, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468814
- Sponsor's protocol ID
- STCOT
- Acronym
- STCCOT
- Status last verified
- May 2024
- First submitted
- 14 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
PubMed 32313774Ludlow KS, Merla JL, Cox JA, Hurst LN. Pillar pain as a postoperative complication of carpal tunnel release: a review of the literature. J Hand Ther. 1997 Oct-Dec;10(4):277-82. doi: 10.1016/s0894-1130(97)80042-7.
PubMed 9399176Murthy PG, Goljan P, Mendez G, Jacoby SM, Shin EK, Osterman AL. Mini-open versus extended open release for severe carpal tunnel syndrome. Hand (N Y). 2015 Mar;10(1):34-9. doi: 10.1007/s11552-014-9650-x.
PubMed 25767419Bai J, Kong L, Zhao H, Yu K, Zhang B, Zhang J, Tian D. Carpal tunnel release with a new mini-incision approach versus a conventional approach, a retrospective cohort study. Int J Surg. 2018 Apr;52:105-109. doi: 10.1016/j.ijsu.2018.02.033. Epub 2018 Feb 20.
PubMed 29471152Khoshnevis J, Layegh H, Yavari N, Eslami G, Afsharfard A, Reza Kalantar-Motamedi SM, Zarrintan S. Comparing open conventional carpal tunnel release with mini-incision technique in the treatment of carpal tunnel syndrome: A non-randomized clinical trial. Ann Med Surg (Lond). 2020 May 16;55:119-123. doi: 10.1016/j.amsu.2020.05.001. eCollection 2020 Jul.
PubMed 32477509Chen 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.
PubMed 24414237Michelotti BM, Vakharia KT, Romanowsky D, Hauck RM. A Prospective, Randomized Trial Comparing Open and Endoscopic Carpal Tunnel Release Within the Same Patient. Hand (N Y). 2020 May;15(3):322-326. doi: 10.1177/1558944718812129. Epub 2018 Nov 21.
PubMed 30461319Shin EK. Endoscopic Versus Open Carpal Tunnel Release. Curr Rev Musculoskelet Med. 2019 Dec;12(4):509-514. doi: 10.1007/s12178-019-09584-0.
PubMed 31773481Kang HJ, Koh IH, Lee TJ, Choi YR. Endoscopic carpal tunnel release is preferred over mini-open despite similar outcome: a randomized trial. Clin Orthop Relat Res. 2013 May;471(5):1548-54. doi: 10.1007/s11999-012-2666-z. Epub 2012 Oct 26.
PubMed 23100191Hu K, Zhang T, Xu W. Intraindividual comparison between open and endoscopic release in bilateral carpal tunnel syndrome: a meta-analysis of randomized controlled trials. Brain Behav. 2016 Feb 16;6(3):e00439. doi: 10.1002/brb3.439. eCollection 2016 Mar.
PubMed 27099801Zuo D, Zhou Z, Wang H, Liao Y, Zheng L, Hua Y, Cai Z. Endoscopic versus open carpal tunnel release for idiopathic carpal tunnel syndrome: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Jan 28;10:12. doi: 10.1186/s13018-014-0148-6.
PubMed 25627324Orhurhu V, Orman S, Peck J, Urits I, Orhurhu MS, Jones MR, Manchikanti L, Kaye AD, Odonkor C, Hirji S, Cornett EM, Imani F, Varrassi G, Viswanath O. Carpal Tunnel Release Surgery- A Systematic Review of Open and Endoscopic Approaches. Anesth Pain Med. 2020 Dec 26;10(6):e112291. doi: 10.5812/aapm.112291. eCollection 2020 Dec.
PubMed 34150584Teng X, Xu J, Yuan H, He X, Chen H. Comparison of Wrist Arthroscopy, Small Incision Surgery, and Conventional Surgery for the Treatment of Carpal Tunnel Syndrome: A Retrospective Study at a Single Center. Med Sci Monit. 2019 Jun 3;25:4122-4129. doi: 10.12659/MSM.912912.
PubMed 31155608Xu L, Huang F, Hou C. Treatment for carpal tunnel syndrome by coronal Z-type lengthening of the transverse carpal ligament. J Pak Med Assoc. 2011 Nov;61(11):1068-71.
PubMed 22125980Castro-Menendez M, Pagazaurtundua-Gomez S, Pena-Paz S, Huici-Izco R, Rodriguez-Casas N, Montero-Vieites A. Z-Elongation of the transverse carpal ligament vs. complete resection for the treatment of carpal tunnel syndrome. Rev Esp Cir Ortop Traumatol. 2016 Nov-Dec;60(6):355-365. doi: 10.1016/j.recot.2016.06.007. Epub 2016 Aug 25. English, Spanish.
PubMed 27569033
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05468814
- Acronym / sponsor ID
- STCCOT / STCOT
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Pillar pain, Grip strength, Pincer strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.
Detailed description
It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied.
The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate" or "severe". As inclusion criteria, patients >18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded.
The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires.
The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list
| Arm | Type | Receives |
|---|---|---|
| Z-plasty | Experimental | Procedure: Z-plastyIt is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch. |
| Conventional | Active comparator | Procedure: ConventionalIt is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Moderate-severe carpal tunnel syndrome
- Symptoms that hinder the patient's daily activities
- Correct conservative treatment without success
Key exclusion criteria (3 listed)
- Previous surgical intervention for carpal tunnel syndrome
- Traumatic or congenital sequelae of the hand
- Incompetence to understand the process and the tests to be carried out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-plastyIt is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch. | Procedure or surgery | Z-plasty |
| ConventionalIt is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. | Procedure or surgery | Conventional |
Primary outcome
Incidence of Pillar Pain
Time frame: 3 weeks after surgery
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
Incidence of Pillar Pain
Time frame: 6 months after surgery
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
8 secondary outcomes
Grip Strength
Time frame: 3 weeks after surgery
Grip Strength
Time frame: 6 months
Pinch Strength
Time frame: 3 weeks
Pinch Strength
Time frame: 6 months
Clinical BCTQ
Time frame: 3 weeks after surgery
Functional BCTQ
Time frame: 6 months
Clinical BCTQ
Time frame: 6 months
Functional BCTQ
Time frame: 3 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32313774Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
- Background: PubMed 9399176Ludlow KS, Merla JL, Cox JA, Hurst LN. Pillar pain as a postoperative complication of carpal tunnel release: a review of the literature. J Hand Ther. 1997 Oct-Dec;10(4):277-82. doi: 10.1016/s0894-1130(97)80042-7.
- Background: PubMed 25767419Murthy PG, Goljan P, Mendez G, Jacoby SM, Shin EK, Osterman AL. Mini-open versus extended open release for severe carpal tunnel syndrome. Hand (N Y). 2015 Mar;10(1):34-9. doi: 10.1007/s11552-014-9650-x.
- Background: PubMed 29471152Bai J, Kong L, Zhao H, Yu K, Zhang B, Zhang J, Tian D. Carpal tunnel release with a new mini-incision approach versus a conventional approach, a retrospective cohort study. Int J Surg. 2018 Apr;52:105-109. doi: 10.1016/j.ijsu.2018.02.033. Epub 2018 Feb 20.
- Background: PubMed 32477509Khoshnevis J, Layegh H, Yavari N, Eslami G, Afsharfard A, Reza Kalantar-Motamedi SM, Zarrintan S. Comparing open conventional carpal tunnel release with mini-incision technique in the treatment of carpal tunnel syndrome: A non-randomized clinical trial. Ann Med Surg (Lond). 2020 May 16;55:119-123. doi: 10.1016/j.amsu.2020.05.001. eCollection 2020 Jul.
- Background: PubMed 24414237Chen 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.
- Background: PubMed 30461319Michelotti BM, Vakharia KT, Romanowsky D, Hauck RM. A Prospective, Randomized Trial Comparing Open and Endoscopic Carpal Tunnel Release Within the Same Patient. Hand (N Y). 2020 May;15(3):322-326. doi: 10.1177/1558944718812129. Epub 2018 Nov 21.
- Background: PubMed 31773481Shin EK. Endoscopic Versus Open Carpal Tunnel Release. Curr Rev Musculoskelet Med. 2019 Dec;12(4):509-514. doi: 10.1007/s12178-019-09584-0.
- Background: PubMed 23100191Kang HJ, Koh IH, Lee TJ, Choi YR. Endoscopic carpal tunnel release is preferred over mini-open despite similar outcome: a randomized trial. Clin Orthop Relat Res. 2013 May;471(5):1548-54. doi: 10.1007/s11999-012-2666-z. Epub 2012 Oct 26.
- Background: PubMed 27099801Hu K, Zhang T, Xu W. Intraindividual comparison between open and endoscopic release in bilateral carpal tunnel syndrome: a meta-analysis of randomized controlled trials. Brain Behav. 2016 Feb 16;6(3):e00439. doi: 10.1002/brb3.439. eCollection 2016 Mar.
- Background: PubMed 25627324Zuo D, Zhou Z, Wang H, Liao Y, Zheng L, Hua Y, Cai Z. Endoscopic versus open carpal tunnel release for idiopathic carpal tunnel syndrome: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Jan 28;10:12. doi: 10.1186/s13018-014-0148-6.
- Background: PubMed 34150584Orhurhu V, Orman S, Peck J, Urits I, Orhurhu MS, Jones MR, Manchikanti L, Kaye AD, Odonkor C, Hirji S, Cornett EM, Imani F, Varrassi G, Viswanath O. Carpal Tunnel Release Surgery- A Systematic Review of Open and Endoscopic Approaches. Anesth Pain Med. 2020 Dec 26;10(6):e112291. doi: 10.5812/aapm.112291. eCollection 2020 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-plasty and Conventional in people with Carpal Tunnel Syndrome, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pillar Pain (time frame: 3 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468814, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.