Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy

NCT ID: NCT01562860

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Median Nerve Compression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Carpal Tunnel and Pronator Teres Release

Patients enrolled in this arm of the study will have both surgical procedures performed at the same time

Group Type ACTIVE_COMPARATOR

dual compression release

Intervention Type PROCEDURE

both procedures will be done on the same day

Carpal Tunnel Release only

Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.

Group Type ACTIVE_COMPARATOR

Pronator Teres Release

Intervention Type PROCEDURE

Surgical release of median nerve compression

dual compression release

Intervention Type PROCEDURE

Both the carpal tunnel compression and the pronator teres compression will be released on the same day.

median nerve release only

Intervention Type PROCEDURE

only the carpal tunnel compression is released

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pronator Teres Release

Surgical release of median nerve compression

Intervention Type PROCEDURE

dual compression release

Both the carpal tunnel compression and the pronator teres compression will be released on the same day.

Intervention Type PROCEDURE

dual compression release

both procedures will be done on the same day

Intervention Type PROCEDURE

median nerve release only

only the carpal tunnel compression is released

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

carpal tunnel release

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal two point discrimination
* Over the age of 18 and under the age of 65

Exclusion Criteria

* Peripheral neuropathy of the median nerve secondary to trauma
* Presence of thoracic outlet syndrome
* Presence of cervical disk disease
* Under the age of 18 and over the age of 65
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tuna Ozyurekoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Christine M. Kleinert Institute for Hand and Microsurgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Christine M. Kleinert Institute for Hand and Microsurgery

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tuna Ozyurekoglu, MD

Role: CONTACT

502-561-4263

Millicent L Horn, BS

Role: CONTACT

502-562-0307

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christina L Kaufman, PhD

Role: primary

502-562-0390

Millicent L Horn, BS

Role: backup

502-562-0307

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10.0039

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bilateral vs Unilateral CTR
NCT01961011 UNKNOWN