Ulnar Nerve Compression, Cubital TunnelPhase 3SPECTRENCT02739945
Sonographic Examination Cubital Tunnel Release
A Phase 3 study testing Cubital tunnel release in people with Ulnar Nerve Compression, Cubital Tunnel, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulnar Nerve Compression, Cubital Tunnel
- What is being tested?
- Cubital tunnel release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Apr 2016
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- history of paresthesia or numbness in the ulnar nerve distribution;
- weakness or wasting of the small muscles of the hand;
- a positive elbow flexion provocation test;
- slowed motor conduction velocity in the ulnar nerve below 50 m/sec.
Who cannot join
- Patients with normal nerve conduction studies;
- prior surgery for Cubital Tunnel Syndrome;
- prior traumatic lesions of the elbow;
- coexistent neurological diseases;
- bone anormalities (cubitus valgus, deformities from previous elbow fractures, osteoarthritis with medial osteophytes ands loose bodies, heterotopic ossifications);
- subluxating ulnar nerve;
- space-occupying soft-tissue lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.
Read the detailed description
The investigators want to compare changes in CSA of the ulnar nerve at the elbow hypothesizing that US examination is a useful tool to detect unsuccessful release and defining which technique shows the best outcome in the first year postoperatively.
The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described. US typically demonstrates an abrupt narrowing and displacement of the nerve within the tunnel, possibly in association with a thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.
- Conditions
- Ulnar Nerve Compression, Cubital Tunnel
- Being tested
- Cubital tunnel release
- Keywords
- Ulnar Nerve Compression, Cubital Tunnel
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cubital tunnel releaseProcedure or surgery
The ulnar nerve is decompressed proximally at the intramuscular septum, decompressed more distally through the cubital tunnel and then exposed between the two heads of the flexor carpi ulnaris muscle. Care is taken to ensure that any point that might compress the ulnar nerve either proximally or distally is evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Open cubital tunnel release | Other | In situ decompression (MacKinnon and Novak 2005) is made through a 6-10 cm longitudinal incision along the course of the ulnar nerve midway between the medial epicondyle and the olecranon. Receives: Procedure: Cubital tunnel release |
| Endoscopic cubital tunnel release | Other | Endoscopic release follows Hoffmann's technique (Hoffmann 2006) that demonstrated the safety and efficacy of this technique in a cadaveric model and in a clinical study. Receives: Procedure: Cubital tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Society Function Score
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
Measured: 12 months postoperatively.
Secondary outcomes (3)
Jamar dynamometer (grip strength)
Quantitative measurement of grip strength were assessed with a Jamar dynamometer. The Jamar Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. The Jamar dynamometer was introduced in 1954 (Bechtol,1954). It consists of a sealed hydraulic system with adjustable hand spacings that measures handgrip force
Measured: 12 months postoperatively.
Static-2 point discrimination test
Two-point discrimination is the ability to discern that two nearby objects touching the skin are truly two distinct points.
Two-point discrimination has long been used as an assessment tool for tactile gnosis, and to assess recovery after a peripheral nerve surgery.
Measured: 12 months postoperatively.
4-point Likert-type scale
Patients undergoing surgical decompression indicate their postoperative clinical outcome on a questionnaire using 4-point Likert-type scale (1= large improvement, 2 = moderate improvement, 3= no improvement, 4= worse than preoperatively)
Measured: 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMay 2011
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ulnar Nerve Compression, Cubital TunnelStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Guidi, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Stefano Lucchina, MD, Study director, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739945
- Sponsor's protocol ID
- EnteOC
- Acronym
- SPECTRE
- Status last verified
- Apr 2016
- First submitted
- 10 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Puig S, Turkof E, Sedivy R, Ciovica R, Lang S, Kainberger FM. Sonographic diagnosis of recurrent ulnar nerve compression by ganglion cysts. J Ultrasound Med. 1999 Jun;18(6):433-6. doi: 10.7863/jum.1999.18.6.433. No abstract available.
PubMed 10361850Martinoli C, Bianchi S, Derchi LE. Ultrasonography of peripheral nerves. Semin Ultrasound CT MR. 2000 Jun;21(3):205-13. doi: 10.1016/s0887-2171(00)90043-x.
PubMed 10994689Okamoto M, Abe M, Shirai H, Ueda N. Diagnostic ultrasonography of the ulnar nerve in cubital tunnel syndrome. J Hand Surg Br. 2000 Oct;25(5):499-502. doi: 10.1054/jhsb.1999.0350.
PubMed 10991822Watts AC, Bain GI. Patient-rated outcome of ulnar nerve decompression: a comparison of endoscopic and open in situ decompression. J Hand Surg Am. 2009 Oct;34(8):1492-8. doi: 10.1016/j.jhsa.2009.05.014. Epub 2009 Aug 20.
PubMed 19695795Hoffmann R, Siemionow M. The endoscopic management of cubital tunnel syndrome. J Hand Surg Br. 2006 Feb;31(1):23-9. doi: 10.1016/j.jhsb.2005.08.008. Epub 2005 Oct 12.
PubMed 16225971King GJ, Richards RR, Zuckerman JD, Blasier R, Dillman C, Friedman RJ, Gartsman GM, Iannotti JP, Murnahan JP, Mow VC, Woo SL. A standardized method for assessment of elbow function. Research Committee, American Shoulder and Elbow Surgeons. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):351-4. doi: 10.1016/s1058-2746(99)90159-3.
PubMed 10472009Chiou HJ, Chou YH, Cheng SP, Hsu CC, Chan RC, Tiu CM, Teng MM, Chang CY. Cubital tunnel syndrome: diagnosis by high-resolution ultrasonography. J Ultrasound Med. 1998 Oct;17(10):643-8. doi: 10.7863/jum.1998.17.10.643.
PubMed 9771609
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
- ClinicalTrials.gov ID
- NCT02739945
- Acronym / sponsor ID
- SPECTRE / EnteOC
- Conditions
- Ulnar Nerve Compression, Cubital Tunnel
- Keywords
- Ulnar Nerve Compression, Cubital Tunnel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Apr 2016 (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 investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.
Detailed description
The investigators want to compare changes in CSA of the ulnar nerve at the elbow hypothesizing that US examination is a useful tool to detect unsuccessful release and defining which technique shows the best outcome in the first year postoperatively.
The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described. US typically demonstrates an abrupt narrowing and displacement of the nerve within the tunnel, possibly in association with a thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open cubital tunnel release | Other | Procedure: Cubital tunnel releaseIn situ decompression (MacKinnon and Novak 2005) is made through a 6-10 cm longitudinal incision along the course of the ulnar nerve midway between the medial epicondyle and the olecranon. |
| Endoscopic cubital tunnel release | Other | Procedure: Cubital tunnel releaseEndoscopic release follows Hoffmann's technique (Hoffmann 2006) that demonstrated the safety and efficacy of this technique in a cadaveric model and in a clinical study. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of paresthesia or numbness in the ulnar nerve distribution;
- weakness or wasting of the small muscles of the hand;
- a positive elbow flexion provocation test;
- slowed motor conduction velocity in the ulnar nerve below 50 m/sec.
Key exclusion criteria (7 listed)
- Patients with normal nerve conduction studies;
- prior surgery for Cubital Tunnel Syndrome;
- prior traumatic lesions of the elbow;
- coexistent neurological diseases;
- bone anormalities (cubitus valgus, deformities from previous elbow fractures, osteoarthritis with medial osteophytes ands loose bodies, heterotopic ossifications);
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 |
|---|---|---|
| Cubital tunnel releaseThe ulnar nerve is decompressed proximally at the intramuscular septum, decompressed more distally through the cubital tunnel and then exposed between the two heads of the flexor carpi ulnaris muscle. Care is taken to ensure that any point that might compress the ulnar nerve either proximally or distally is evaluated. | Procedure or surgery | Endoscopic cubital tunnel release, Open cubital tunnel release |
Primary outcome
American Shoulder and Elbow Society Function Score
Time frame: 12 months postoperatively.
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
3 secondary outcomes
Jamar dynamometer (grip strength)
Time frame: 12 months postoperatively.
Static-2 point discrimination test
Time frame: 12 months postoperatively.
4-point Likert-type scale
Time frame: 12 months postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 10361850Puig S, Turkof E, Sedivy R, Ciovica R, Lang S, Kainberger FM. Sonographic diagnosis of recurrent ulnar nerve compression by ganglion cysts. J Ultrasound Med. 1999 Jun;18(6):433-6. doi: 10.7863/jum.1999.18.6.433. No abstract available.
- Background: PubMed 10994689Martinoli C, Bianchi S, Derchi LE. Ultrasonography of peripheral nerves. Semin Ultrasound CT MR. 2000 Jun;21(3):205-13. doi: 10.1016/s0887-2171(00)90043-x.
- Background: PubMed 10991822Okamoto M, Abe M, Shirai H, Ueda N. Diagnostic ultrasonography of the ulnar nerve in cubital tunnel syndrome. J Hand Surg Br. 2000 Oct;25(5):499-502. doi: 10.1054/jhsb.1999.0350.
- Background: PubMed 19695795Watts AC, Bain GI. Patient-rated outcome of ulnar nerve decompression: a comparison of endoscopic and open in situ decompression. J Hand Surg Am. 2009 Oct;34(8):1492-8. doi: 10.1016/j.jhsa.2009.05.014. Epub 2009 Aug 20.
- Background: PubMed 16225971Hoffmann R, Siemionow M. The endoscopic management of cubital tunnel syndrome. J Hand Surg Br. 2006 Feb;31(1):23-9. doi: 10.1016/j.jhsb.2005.08.008. Epub 2005 Oct 12.
- Background: PubMed 10472009King GJ, Richards RR, Zuckerman JD, Blasier R, Dillman C, Friedman RJ, Gartsman GM, Iannotti JP, Murnahan JP, Mow VC, Woo SL. A standardized method for assessment of elbow function. Research Committee, American Shoulder and Elbow Surgeons. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):351-4. doi: 10.1016/s1058-2746(99)90159-3.
- Results publication: PubMed 9771609Chiou HJ, Chou YH, Cheng SP, Hsu CC, Chan RC, Tiu CM, Teng MM, Chang CY. Cubital tunnel syndrome: diagnosis by high-resolution ultrasonography. J Ultrasound Med. 1998 Oct;17(10):643-8. doi: 10.7863/jum.1998.17.10.643.
- Individual participant dataSharing planned: No
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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.
Stefano Lucchina, MD study director
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cubital tunnel release in people with Ulnar Nerve Compression, Cubital Tunnel, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 7 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 15 Apr 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American Shoulder and Elbow Society Function Score (time frame: 12 months postoperatively.). 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 NCT02739945, which also lists 7 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 15 Apr 2016.