Carpal Tunnel SyndromePhase 2CTS-HVNCT01756820
Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial
A Phase 2 study testing Single-portal Endoscopic Carpal Tunnel Release (Microaire®) and Knifelight in people with Carpal Tunnel Syndrome, run by University of Ioannina at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Single-portal Endoscopic Carpal Tunnel Release (Microaire®) and Knifelight
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary Carpal Tunnel Syndrome
- no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
- electrophysiological examination confirms the Carpal Tunnel Syndrome
Who cannot join
- Secondary Carpal Tunnel Syndrome
- Pregnancy
- Rheumatoid diseases
- Previous trauma at hand or other condition that may effect the anatomy (eg infections)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Single-portal Endoscopic Carpal Tunnel Release (Microaire®), Knifelight
- Keywords
- Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve
- 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.
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)Procedure or surgery
Also called SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.
SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).
KnifelightProcedure or surgery
Also called Knifelight®, Stryker
A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)
| Study group | Role | What they receive |
|---|---|---|
| Single-portal Endoscopic Carpal Tunnel Release (Microaire®) | Active comparator | Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al. Receives: Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®) |
| Knifelight® | Active comparator | A mini-open technique will be performed, using the Knifelight® (Stryker). Receives: Procedure: Knifelight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Satisfaction
Satisfaction will be assessed by two ways
- by answering to the question "are you happy with the result of the surgery?"
- with a VAS score (0-100) assessing the satisfaction
Measured: at 1 and 6 months postoperatively
Complications
Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc
Measured: up to 6 months postoperatively
Secondary outcomes (7)
Pain
Pain will be assessed
- as a dichotomous outcome (yes/no)
- as a continuous outcome (VAS score)
Measured: at 1 and 6 months postoperatively
Grip strength
Measured: at 1 and 6 months postoperatively
key pinch
Measured: at 1 and 6 months postoperatively
Time to return to Activities of Daily Living (ADL) and return to work
Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.
Measured: up to the end of the study
Recurrences and reoperations
Measured: up to the end of study
Symptom Severity Scale (SSS)
Measured: at 1 and 6 months postoperatively
Function Severity Status (FSS)
Measured: at 1 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: The principal investigator of the study relocated to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haris S Vasiliadis, MD, PhD, University of Ioannina
- Investigators
- Haris S Vasiliadis, MD, PhD, Principal investigator, Department of Orthopaedics, School of Medicine, University of Ioannina, GreeceTheodoros Xenakis, Study chair, Department of Orthopaedics, School of Medicine, University of Ioannina, GreeceGrigorios Mitsionis, Study director, Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756820
- Sponsor's protocol ID
- Ioannina-CTS-HV
- Acronym
- CTS-HV
- Status last verified
- May 2016
- First submitted
- 20 Dec 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01756820
- Acronym / sponsor ID
- CTS-HV / Ioannina-CTS-HV
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator of the study relocated to another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 27 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-portal Endoscopic Carpal Tunnel Release (Microaire®) | Active comparator | Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al. |
| Knifelight® | Active comparator | Procedure: KnifelightA mini-open technique will be performed, using the Knifelight® (Stryker). |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary Carpal Tunnel Syndrome
- no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
Key exclusion criteria (4 listed)
- Secondary Carpal Tunnel Syndrome
- Pregnancy
- Rheumatoid diseases
- Previous trauma at hand or other condition that may effect the anatomy (eg infections)
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 |
|---|---|---|
| Single-portal Endoscopic Carpal Tunnel Release (Microaire®)Also: SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/). | Procedure or surgery | Single-portal Endoscopic Carpal Tunnel Release (Microaire®) |
| KnifelightAlso: Knifelight®, StrykerA mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach) | Procedure or surgery | Knifelight® |
Primary outcome
Overall Satisfaction
Time frame: at 1 and 6 months postoperatively
Satisfaction will be assessed by two ways * by answering to the question "are you happy with the result of the surgery?" * with a VAS score (0-100) assessing the satisfaction
Complications
Time frame: up to 6 months postoperatively
Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc
7 secondary outcomes
Pain
Time frame: at 1 and 6 months postoperatively
Grip strength
Time frame: at 1 and 6 months postoperatively
key pinch
Time frame: at 1 and 6 months postoperatively
Time to return to Activities of Daily Living (ADL) and return to work
Time frame: up to the end of the study
Recurrences and reoperations
Time frame: up to the end of study
Symptom Severity Scale (SSS)
Time frame: at 1 and 6 months postoperatively
Function Severity Status (FSS)
Time frame: at 1 and 6 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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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.
Haris S Vasiliadis, MD, PhD principal investigator
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
Theodoros Xenakis study chair
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
Grigorios Mitsionis study director
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single-portal Endoscopic Carpal Tunnel Release (Microaire®) and Knifelight in people with Carpal Tunnel Syndrome, run by University of Ioannina at 1 site in Greece.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 May 2016. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Satisfaction (time frame: at 1 and 6 months postoperatively). 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?
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 11 May 2016.