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NCT01621126 · ClinicalTrials.gov registry record · NA

Neuromonitoring During the Latarjet Procedure

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT01621126: Completed NA study, sponsored by Massachusetts General Hospital.

NCT01621126 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01621126, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

In a study performed by the Harvard Shoulder Service, it has been documented that there is a significant incidence of neurologic complications of the Latarjet procedure for shoulder instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these nerve palsies were transient, however 2 had not yet recovered fully at time of latest follow-up and returned to the operating room for exploration and neurolysis of the axillary nerve and brachial plexus. By using intra-operative neuromonitoring to determine exactly when there is a potential nerve injury during the procedure, the investigators will be able to modify what the investigators do at that step of the procedure, in order to decrease or possibly even eliminate the risk of neurologic injury.

Primary Outcome

Nerve palsy of any nerve(s) in the operative upper extremity.

Interventions

  • DEVICE Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2011-06
Est. Completion 2014-10
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT01621126 record still lists

NCT01621126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor) is the first listed.

NCT01621126 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01621126 about?

NCT01621126 is a clinical study titled "Neuromonitoring During the Latarjet Procedure". In a study performed by the Harvard Shoulder Service, it has been documented that there is a significant incidence of neurologic complications of the Latarjet procedure for shoulder instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these nerve palsies were transient,...

What is the current status of trial NCT01621126?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2011-06. Estimated completion is 2014-10.

What interventions are being tested in trial NCT01621126?

The interventions under investigation include: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor) (DEVICE).

Who is sponsoring clinical trial NCT01621126?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01621126's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01621126, the US trial registry maintained by the National Library of Medicine. NCT01621126 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.