Ulnar Nerve TranspositionNCT07880470
Is Splinting After Ulnar Nerve Transposition Necessary?
A study testing Stiff splint and No splint in people with Ulnar Nerve Transposition, run by University of Chicago at 5 sites in United States.
Trial summary
The goal of this clinical trial is to learn whether patient recovery after ulnar nerve transposition (UNT) requires a splint. The main questions it aims to answer are: Does the effect that early versus delayed mobilization after UNT have on patient sleep quality differ? What are the medical complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulnar Nerve Transposition
- What is being tested?
- Stiff splint and No splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Indicated for Ulnar Nerve Transposition
- Able and willing to complete online questionnaires
- Able and willing to provide written informed consent
Who cannot join
- Additional procedures to be performed on ipsilateral or contralateral extremity
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
UChicago Medicine at Ingalls - Calumet City
Calumet City, Illinois, 60409
Daniel Hong, MD, 773-906-4605, daniel.hong@bsd.uchicago.edu
UChicago Medicine Crown Point
Crown Point, Indiana, 46307
Daniel Hong, MD, 773-906-4605, daniel.hong@bsd.uchicago.edu
University of Chicago Medical Center
Hyde Park, Illinois, 60637
Daniel Hong, MD, 773-906-4605, daniel.hong@bsd.uchicago.edu
Daniel Y Hong, MD
UChicago Medicine Orland Park
Orland Park, Illinois, 60462
Daniel Hong, MD, 773-906-4605, daniel.hong@bsd.uchicago.edu
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477
Daniel Hong, MD, 773-906-4605, daniel.hong@bsd.uchicago.edu
About this study
The goal of this clinical trial is to learn whether patient recovery after ulnar nerve transposition (UNT) requires a splint. The main questions it aims to answer are:
- Does the effect that early versus delayed mobilization after UNT have on patient sleep quality differ?
- What are the medical complications, reoperations, and timeline of returning to work that result from this procedure like?
Participants will be placed in a stiff splint (that limits elbow movement) or no splint (that allows for earlier elbow movement) after this surgery. Participants will report their recovery through surveys measuring physical function, pain, and sleep. Researchers will compare the results between the two types of splinting.
- Conditions
- Ulnar Nerve Transposition
- Being tested
- Stiff splint, No splint
- Keywords
- Ulnar nerve transposition, Splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stiff splintProcedure or surgery
Participants receive a stiff splint that limits elbow movement
No splintProcedure or surgery
Participants receive a soft dressing that allows for movement.
| Study group | Role | What they receive |
|---|---|---|
| Stiff Splint | Active comparator | Participants receive a stiff splint that limits elbow movement Receives: Procedure: Stiff splint |
| No splint | Active comparator | Participants receive a soft dressing that allows for movement. Receives: Procedure: No splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburg Sleep Quality Index scores
A survey that measures self reported sleep measures from a score of 0 to 21 and a score over 5 indicates sleep difficulties and poor sleep quality.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (4)
Patient Reported Outcome Measures Information System (PROMIS)
The PROMIS physical function instrument measures self reported capability for daily physical activities and is scored on standardized norm-based-T-score where higher scores indicate greater physical capacity and functioning. The PROMIS upper extremity instrument measures physical capability related to the hand, wrist, arm and shoulder. Responses are scored on a standardized norm-based-T-score where higher scores indicate better function. The PROMIS Pain Interference instrument measures daily pain levels and how they interrupt daily function. Responses are scored on a standardized norm-based-T-score where higher scores indicate greater pain interference.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Average Patient-Reported Activity Level and Recovery Satisfaction
Measures how quickly the participant returns to normal function in daily life and activity in weeks. Each questionnaire has two scales that are asked at each time point up to one year post-surgery. One asks about current activity level compared to pre-surgery on a scale of 1-10 with 1 being significantly less active and 10 being significantly more active. The other asks about satisfaction with the recovery process on a scale of 1-10 with 1 being very dissatisfied and 10 being very satisfied.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Number of Patients with Post operative complications
Includes rates of complications (wound dehiscence, recurrent nerve instability, hematoma formation) and reoperation measured by yes or no question at each timepoint.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Change in Degrees of Elbow Range of Motion
Measures the change in elbow flexion after the procedure compared to the pre-operative baseline. The evaluation is performed during the standard clinical exam with a continuous scale of 0-145 degrees with a larger degree of flexion indicating better recovery and joint mobility.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Nerve TranspositionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880470
- Sponsor's protocol ID
- IRB26-0352
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Splinting After Ulnar Nerve Transposition Necessary?
- ClinicalTrials.gov ID
- NCT07880470
- Acronym / sponsor ID
- IRB26-0352
- Conditions
- Ulnar Nerve Transposition
- Keywords
- Ulnar nerve transposition, Splinting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- 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 goal of this clinical trial is to learn whether patient recovery after ulnar nerve transposition (UNT) requires a splint. The main questions it aims to answer are:
- Does the effect that early versus delayed mobilization after UNT have on patient sleep quality differ?
- What are the medical complications, reoperations, and timeline of returning to work that result from this procedure like?
Participants will be placed in a stiff splint (that limits elbow movement) or no splint (that allows for earlier elbow movement) after this surgery. Participants will report their recovery through surveys measuring physical function, pain, and sleep. Researchers will compare the results between the two types of splinting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stiff Splint | Active comparator | Procedure: Stiff splintParticipants receive a stiff splint that limits elbow movement |
| No splint | Active comparator | Procedure: No splintParticipants receive a soft dressing that allows for movement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Indicated for Ulnar Nerve Transposition
- Able and willing to complete online questionnaires
- Able and willing to provide written informed consent
Key exclusion criteria (1 listed)
- Additional procedures to be performed on ipsilateral or contralateral extremity
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 |
|---|---|---|
| Stiff splintParticipants receive a stiff splint that limits elbow movement | Procedure or surgery | Stiff Splint |
| No splintParticipants receive a soft dressing that allows for movement. | Procedure or surgery | No splint |
Primary outcome
Pittsburg Sleep Quality Index scores
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
A survey that measures self reported sleep measures from a score of 0 to 21 and a score over 5 indicates sleep difficulties and poor sleep quality.
4 secondary outcomes
Patient Reported Outcome Measures Information System (PROMIS)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Average Patient-Reported Activity Level and Recovery Satisfaction
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Number of Patients with Post operative complications
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Change in Degrees of Elbow Range of Motion
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Ulnar Nerve Transposition
Active, not recruiting
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Neuropathy Ulnar
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.
UChicago Medicine at Ingalls - Calumet City
Calumet City, United States
University of Chicago Medical Center
Hyde Park, United States
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stiff splint and No splint in people with Ulnar Nerve Transposition, run by University of Chicago at 5 sites in United States.
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 1 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburg Sleep Quality Index scores (time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year). 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 22 Oct 2026.