Peripheral Nervous System DiseasesUNETREATNCT03651609

Treatment for Ulnar Neuropathy at the Elbow

A study testing Simple decompression of the ulnar nerve and Conservative treatment in people with Peripheral Nervous System Diseases and Nerve Compression Syndromes, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Peripheral Nervous System Diseases, Nerve Compression Syndromes, Cubital Tunnel Syndrome
What is being tested?: Simple decompression of the ulnar nerve and Conservative treatment
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteSlovenia
Study dates: 1 Jan 2019to 1 Mar 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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

continuous numbness or paresthesias in the 5th ﬁnger,
weakness of the ulnar-innervated muscles or hand clumsiness.

Who cannot join

previous elbow fracture or surgery,
polyneuropathy, symptoms of polyneuropathy, conditions causing polyneuropathy (e.g., diabetes) or multiple mononeuropathy,
motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS).

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Treatment for Ulnar Neuropathy at the Elbow - a Randomized Control Trial

The purpose of the study is to investigate utility and appropriateness of treatment interventions taking into account the presumed mechanisms of two main varieties of ulnar neuropathy at the elbow (UNE). The investigators hypothesize that in patients with UNE by entrapment in the cubital tunnel (CTE) surgical release (simple decompression) is superior to conservative treatment. By contrast, in patients with UNE in the retrocondylar groove (RCC) surgical humero-ulnar apponeurosis (HUA) release (simple decompression) should not be superior to conservative treatment.

Read the detailed description

Ulnar neuropathy at the elbow (UNE) is the second most common focal neuropathy with annual incidence rate of 21 per 100.000. Therefore, in Slovenia UNE each year affects approximately 420 and in Europe 156.000 patients. In previous publications evidence was presented that idiopathic UNE consists of two conditions occurring 2-5 cm apart. In the first condition, affecting about 15% of UNE patients, the ulnar nerve is entrapped 2-3 cm distal to the medial epicondyle (ME) in the cubital tunnel (CTE). In the second condition, affecting the majority (about 85%) of patients, the lesion is located at the ME or up to 4 cm proximally in the retrocondylar groove (RCC). As no anatomical structure constricting the ulnar nerve is usually found in that segment, the most probable cause of UNE at this location is extrinsic ulnar nerve compression against the underlying bone. The investigators believe that these two groups of UNE patients need different therapeutic approaches: (1) surgical release for ulnar nerve entrapment distal to ME and (2) conservative treatment for extrinsic nerve compression in the RCC. The efficiency of this therapeutic approach was already evaluated and significant clinical improvement was found in 80% of UNE patients. However, the design of that study did not enable to obtain an indisputable evidence that outcome was a result of treatment approach. It is still possible that improvement observed in patient population was a consequence of natural history rather than therapy. To resolve this problem a properly designed randomized control trial is needed. The investigators believe such trial would prevent numerous unnecessary and delayed operations in UNE patients.

Conditions: Peripheral Nervous System Diseases, Nerve Compression Syndromes, Cubital Tunnel Syndrome
Being tested: Simple decompression of the ulnar nerve, Conservative treatment
Keywords: Ulnar neuropathy at the elbow, Electromyography, Ultrasonography, Treatment, Surgery, Conservative treatment
Medical subject headings: Peripheral Nervous System Diseases, Nerve Compression Syndromes, Cubital Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Simple decompression of the ulnar nerveProcedure or surgery
Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .
Conservative treatmentBehavioural
Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.

Study groups in NCT03651609
Study group	Role	What they receive
UNE by CTE_surgery	Experimental	Patients with UNE by CTE randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. Control neurological examination will be performed every 3 months and identical protocol as at the time of diagnostic evaluation at 1 year follow-up. Receives: Procedure: Simple decompression of the ulnar nerve; Behavioral: Conservative treatment
UNE by CTE_conservative treatment	Active comparator	Patients with UNE by CTE randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. In order to prevent deterioration in conservatively treated group of patients with UNE by CTE control neurological examination will be performed every 3 months. Criteria for surgical release will be clinical deterioration or lack of clinical improvement after 12 months. Prior to surgical release and at 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed. Receives: Behavioral: Conservative treatment
UNE at RCC_surgery	Experimental	Patients with UNE at RCC randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed. Receives: Procedure: Simple decompression of the ulnar nerve; Behavioral: Conservative treatment
UNE at RCC_conservative treatment	Active comparator	Patients with UNE at RCC randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed. Receives: Behavioral: Conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

UNEQ Score
The primary outcome measure was the change in standard questionnaire for assessment of UNE severity (UNEQ) score from baseline at inclusion of patients into the study and at 12-month follow-up. The UNEQ considers the patient's numbness and tingling of the last two fingers, elbow pain, and changes in these symptoms with elbow position. It also evaluates hand weakness. Questionnaire items were graded as: 1 - absent, 2 - mild, 3 - moderate, 4 - severe, or 5 - very severe. The final UNEQ score was calculated as the mean of the nine items.
Measured: 1 year

Secondary outcomes (9)

Clinical UNE Severity
Clinical UNE severity was graded: (1) Mild UNE - reduced sensation in the ulnar-innervated areas; (2) Moderate UNE - + ulnar hand muscle weakness, and (3) Severe UNE - + at least moderate ulnar hand muscle atrophy.
Measured: 1 years
Muscle Wasting
The percentage of patients with reduction in ulnar-innervated hand muscle atrophy
Measured: 1 years
Muscles Strength
The percentage of patients with increased ADM/FDI muscle MRC grade
Measured: 1 years
Light Touch 5th Finger
Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent
Measured: 1 year
Ulnar_MNCV
The percentage of patients with >30% increase in MNCVmin
Measured: 1 years
Ulnar_CMAP_AMP
The amplitude of the ulnar CMAP on stimulation at D4
Measured: 1 years
Ulnar_SNAP_AMP
The amplitude of the ulnar SNAP from the 5th finger
Measured: 1 year
Ulnar Nerve CSAmax
ulnar nerve CSAmax in the elbow segment
Measured: 1 year
Ulnar Nerve CSAmin
Ulnar nerve CSAmin in the elbow segment
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20191 Mar 2023

First posted29 Aug 2018
Study start1 Jan 2019
Primary completion1 Mar 2023
Study completion1 Mar 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 (12)Papers the sponsor has linked to this study.
Other trials for Peripheral Nervous System DiseasesStudies 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: The study will have a parallel trial design with a 1:1 allocation ratio. CTE and RCC patients will be separately randomized throwing dice as follows: (1) even number - surgical release; and (2) odd number - conservative treatment. In patients with bilateral UNE, the more affected arm will be randomized. Patients randomized to the surgical arm will be referred to a plastic surgeon. All included CTE and RCC patients (including those randomized to surgical release) will be given illustrated instructions showing arm positions to avoid to prevent further ulnar nerve damage. The examiners will be blinded as far as possible to the patient's study arm and to the findings of other parts of the evaluation. Patients will not be blinded to treatment.
Masking: Single blind
Who is masked: Investigator
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03651609
Sponsor's protocol ID: UNE Treatment
Acronym: UNETREAT
Status last verified: Aug 2025
First submitted: 27 Aug 2018
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after de-identification.

Publications

Omejec G, Podnar S. Precise localization of ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Dec;126(12):2390-6. doi: 10.1016/j.clinph.2015.01.023. Epub 2015 Feb 14.
PubMed 25743266
Omejec G, Podnar S. What causes ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Jan;127(1):919-924. doi: 10.1016/j.clinph.2015.05.027. Epub 2015 Jun 17.
PubMed 26093933
Simon NG. Treatment of ulnar neuropathy at the elbow - An ongoing conundrum. Clin Neurophysiol. 2018 Aug;129(8):1716-1717. doi: 10.1016/j.clinph.2018.06.006. Epub 2018 Jun 18. No abstract available.
PubMed 29934265
Omejec G, Podnar S. Long-term outcomes in patients with ulnar neuropathy at the elbow treated according to the presumed aetiology. Clin Neurophysiol. 2018 Aug;129(8):1763-1769. doi: 10.1016/j.clinph.2018.04.753. Epub 2018 Jun 1.
PubMed 29887400
Omejec G, Zgur T, Podnar S. Diagnostic accuracy of ultrasonographic and nerve conduction studies in ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Sep;126(9):1797-804. doi: 10.1016/j.clinph.2014.12.001. Epub 2014 Dec 8.
PubMed 25541522
Omejec G, Podnar S. Normative values for short-segment nerve conduction studies and ultrasonography of the ulnar nerve at the elbow. Muscle Nerve. 2015 Mar;51(3):370-7. doi: 10.1002/mus.24328. Epub 2015 Jan 10.
PubMed 24985195
Omejec G, Podnar S. Proposal for electrodiagnostic evaluation of patients with suspected ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Apr;127(4):1961-7. doi: 10.1016/j.clinph.2016.01.011. Epub 2016 Jan 28.
PubMed 26971477
Omejec G, Zgur T, Podnar S. Can neurologic examination predict pathophysiology of ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Oct;127(10):3259-64. doi: 10.1016/j.clinph.2016.08.002. Epub 2016 Aug 9.
PubMed 27552333
Omejec G, Bozikov K, Podnar S. Validation of preoperative nerve conduction studies by intraoperative studies in patients with ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Dec;127(12):3499-3505. doi: 10.1016/j.clinph.2016.09.018. Epub 2016 Oct 13.
PubMed 27815973
Omejec G, Podnar S. Neurologic examination and instrument-based measurements in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 2018 Jun;57(6):951-957. doi: 10.1002/mus.26046. Epub 2018 Jan 23.
PubMed 29266317
Podnar S, Omejec G, Bodor M. Nerve conduction velocity and cross-sectional area in ulnar neuropathy at the elbow. Muscle Nerve. 2017 Dec;56(6):E65-E72. doi: 10.1002/mus.25655. Epub 2017 Apr 15.
PubMed 28345147
Leis AA, Smith BE, Kosiorek HE, Omejec G, Podnar S. Complete dislocation of the ulnar nerve at the elbow: a protective effect against neuropathy? Muscle Nerve. 2017 Aug;56(2):242-246. doi: 10.1002/mus.25483. Epub 2017 Jan 4.
PubMed 27859367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Peripheral Nervous System Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment for Ulnar Neuropathy at the Elbow - a Randomized Control Trial
ClinicalTrials.gov ID: NCT03651609
Acronym / sponsor ID: UNETREAT / UNE Treatment
Conditions: Peripheral Nervous System Diseases, Nerve Compression Syndromes, Cubital Tunnel Syndrome
Keywords: Ulnar neuropathy at the elbow, Electromyography, Ultrasonography, Treatment, Surgery, Conservative treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: University Medical Centre LjubljanaUniversity, hospital or other
Collaborators: Slovenian Research Agency
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4
Model description: The study will have a parallel trial design with a 1:1 allocation ratio. CTE and RCC patients will be separately randomized throwing dice as follows: (1) even number - surgical release; and (2) odd number - conservative treatment. In patients with bilateral UNE, the more affected arm will be randomized. Patients randomized to the surgical arm will be referred to a plastic surgeon. All included CTE and RCC patients (including those randomized to surgical release) will be given illustrated instructions showing arm positions to avoid to prevent further ulnar nerve damage. The examiners will be blinded as far as possible to the patient's study arm and to the findings of other parts of the evaluation. Patients will not be blinded to treatment.

Arm	Type	Receives
UNE by CTE_surgery	Experimental	Procedure: Simple decompression of the ulnar nerve, Behavioral: Conservative treatmentPatients with UNE by CTE randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. Control neurological examination will be performed every 3 months and identical protocol as at the time of diagnostic evaluation at 1 year follow-up.
UNE by CTE_conservative treatment	Active comparator	Behavioral: Conservative treatmentPatients with UNE by CTE randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. In order to prevent deterioration in conservatively treated group of patients with UNE by CTE control neurological examination will be performed every 3 months. Criteria for surgical release will be clinical deterioration or lack of clinical improvement after 12 months. Prior to surgical release and at 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.
UNE at RCC_surgery	Experimental	Procedure: Simple decompression of the ulnar nerve, Behavioral: Conservative treatmentPatients with UNE at RCC randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.
UNE at RCC_conservative treatment	Active comparator	Behavioral: Conservative treatmentPatients with UNE at RCC randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

continuous numbness or paresthesias in the 5th ﬁnger,
weakness of the ulnar-innervated muscles or hand clumsiness.

Key exclusion criteria (3 listed)

previous elbow fracture or surgery,
polyneuropathy, symptoms of polyneuropathy, conditions causing polyneuropathy (e.g., diabetes) or multiple mononeuropathy,
motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS).

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
Simple decompression of the ulnar nerveSurgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .	Procedure or surgery	UNE at RCC_surgery, UNE by CTE_surgery
Conservative treatmentPatients will be given pictured recommendations with descriptions, which limb positions should be avoided.	Behavioural	UNE at RCC_conservative treatment, UNE at RCC_surgery, UNE by CTE_conservative treatment, UNE by CTE_surgery

Primary outcome

UNEQ Score
Time frame: 1 year
The primary outcome measure was the change in standard questionnaire for assessment of UNE severity (UNEQ) score from baseline at inclusion of patients into the study and at 12-month follow-up. The UNEQ considers the patient's numbness and tingling of the last two fingers, elbow pain, and changes in these symptoms with elbow position. It also evaluates hand weakness. Questionnaire items were graded as: 1 - absent, 2 - mild, 3 - moderate, 4 - severe, or 5 - very severe. The final UNEQ score was calculated as the mean of the nine items.

9 secondary outcomes

Clinical UNE Severity
Time frame: 1 years
Muscle Wasting
Time frame: 1 years
Muscles Strength
Time frame: 1 years
Light Touch 5th Finger
Time frame: 1 year
Ulnar_MNCV
Time frame: 1 years
Ulnar_CMAP_AMP
Time frame: 1 years
Ulnar_SNAP_AMP
Time frame: 1 year
Ulnar Nerve CSAmax
Time frame: 1 year
Ulnar Nerve CSAmin
Time frame: 1 year

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UNE by CTE_surgery	34	32
UNE by CTE_conservative Treatment	33	33
UNE at RGC_surgery	36	33
UNE at RGC_conservative Treatment	35	32

Primary outcome: UNEQ Score

Time frame: 1 year. Median (Inter-Quartile Range). Unit: score on a scale

Measure	UNE by CTE_surgery n = 32	UNE by CTE_conservative Treatment n = 33	UNE at RCC_surgery n = 33	UNE at RCC_conservative Treatment n = 32
Baseline	2 (1.8 to 2.3)	2 (1.8 to 2.2)	1.9 (1.8 to 2)	1.9 (1.8 to 2)
12 monts	1.7 (1.4 to 1.8)	2 (1.8 to 2.1)	1.4 (1.3 to 1.7)	1.6 (1.3 to 1.7)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UNE by CTE_surgery	0 of 32 (0%)	0 of 32 (0%)	0 of 32
UNE by CTE_conservative Treatment	0 of 33 (0%)	0 of 33 (0%)	0 of 33
UNE at RGC_surgery	0 of 33 (0%)	0 of 33 (0%)	0 of 33
UNE at RGC_conservative Treatment	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25743266Omejec G, Podnar S. Precise localization of ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Dec;126(12):2390-6. doi: 10.1016/j.clinph.2015.01.023. Epub 2015 Feb 14.
Background: PubMed 26093933Omejec G, Podnar S. What causes ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Jan;127(1):919-924. doi: 10.1016/j.clinph.2015.05.027. Epub 2015 Jun 17.
Background: PubMed 29934265Simon NG. Treatment of ulnar neuropathy at the elbow - An ongoing conundrum. Clin Neurophysiol. 2018 Aug;129(8):1716-1717. doi: 10.1016/j.clinph.2018.06.006. Epub 2018 Jun 18. No abstract available.
Background: PubMed 29887400Omejec G, Podnar S. Long-term outcomes in patients with ulnar neuropathy at the elbow treated according to the presumed aetiology. Clin Neurophysiol. 2018 Aug;129(8):1763-1769. doi: 10.1016/j.clinph.2018.04.753. Epub 2018 Jun 1.
Background: PubMed 25541522Omejec G, Zgur T, Podnar S. Diagnostic accuracy of ultrasonographic and nerve conduction studies in ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Sep;126(9):1797-804. doi: 10.1016/j.clinph.2014.12.001. Epub 2014 Dec 8.
Background: PubMed 24985195Omejec G, Podnar S. Normative values for short-segment nerve conduction studies and ultrasonography of the ulnar nerve at the elbow. Muscle Nerve. 2015 Mar;51(3):370-7. doi: 10.1002/mus.24328. Epub 2015 Jan 10.
Background: PubMed 26971477Omejec G, Podnar S. Proposal for electrodiagnostic evaluation of patients with suspected ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Apr;127(4):1961-7. doi: 10.1016/j.clinph.2016.01.011. Epub 2016 Jan 28.
Background: PubMed 27552333Omejec G, Zgur T, Podnar S. Can neurologic examination predict pathophysiology of ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Oct;127(10):3259-64. doi: 10.1016/j.clinph.2016.08.002. Epub 2016 Aug 9.
Background: PubMed 27815973Omejec G, Bozikov K, Podnar S. Validation of preoperative nerve conduction studies by intraoperative studies in patients with ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Dec;127(12):3499-3505. doi: 10.1016/j.clinph.2016.09.018. Epub 2016 Oct 13.
Background: PubMed 29266317Omejec G, Podnar S. Neurologic examination and instrument-based measurements in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 2018 Jun;57(6):951-957. doi: 10.1002/mus.26046. Epub 2018 Jan 23.
Background: PubMed 28345147Podnar S, Omejec G, Bodor M. Nerve conduction velocity and cross-sectional area in ulnar neuropathy at the elbow. Muscle Nerve. 2017 Dec;56(6):E65-E72. doi: 10.1002/mus.25655. Epub 2017 Apr 15.
Background: PubMed 27859367Leis AA, Smith BE, Kosiorek HE, Omejec G, Podnar S. Complete dislocation of the ulnar nerve at the elbow: a protective effect against neuropathy? Muscle Nerve. 2017 Aug;56(2):242-246. doi: 10.1002/mus.25483. Epub 2017 Jan 4.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification.

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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.

Simon Podnar, MD, DSc principal investigator

Department of Neurology, University Medical Center Ljubljana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 14 Aug 2025. 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 Slovenia. 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 14 Aug 2025). 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?

UNEQ Score (time frame: 1 year). 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 NCT03651609, which also lists 12 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 14 Aug 2025.