Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

April 27, 2026 updated by: Vehniah Tjong, Northwestern University

Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?

Compared to the knee and shoulder, the hip joint leaves relatively little space to maneuver arthroscopic instruments and camera. To expand the potential space in the hip joint, traction is commonly applied to the operative leg through a perineal post. This is an effective technique to improve the working space for arthroscopy, however it has been associated with complications, including perineal numbness. Traction pads, used alone or with a perineal post, can reduce pressure on the perineal area, thus reducing numbness. The investigators hypothesize that positioning hip arthroscopy patients using a traction pad on a standard traction table with a perineal post will reduce the incidence and duration of postoperative perineal numbness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
  • Ability to read and speak English

Exclusion Criteria:

  • Revision surgery
  • Oncologic surgery
  • Use of regional anesthesia
  • Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pink Pad
Hip arthroscopy using The Pink Pad Hip Kit Patient Positioning System (Xodus Medical, New Kensington, PA). The pad is placed between the patient and the traction table, using a perineal post.
Device: The Pink Pad Hip Kit
The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.
Other Names:
  • Xodus Medical
No Intervention: Control (No pad)
Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
patient-reported post-operative numbness
Time Frame: Baseline prior to surgery
Y/N Are you experiencing complete or partial numbness prior to your surgery?
Baseline prior to surgery
patient-reported post-operative numbness
Time Frame: 72 hours after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
72 hours after surgery
patient-reported numbness
Time Frame: 1 week after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
1 week after surgery
patient-reported numbness
Time Frame: 3 weeks after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
3 weeks after surgery
patient-reported numbness
Time Frame: 6 weeks after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
6 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
patient-reported difficulty urinating
Time Frame: Baseline prior to surgery
Y/N Have you experienced difficulty urinating?
Baseline prior to surgery
patient-reported difficulty urinating
Time Frame: 72 hours after surgery
Y/N Have you experienced difficulty urinating?
72 hours after surgery
patient-reported difficulty urinating
Time Frame: 1 week after surgery
Y/N Have you experienced difficulty urinating?
1 week after surgery
patient-reported difficulty urinating
Time Frame: 3 weeks after surgery
Y/N Have you experienced difficulty urinating?
3 weeks after surgery
patient-reported difficulty urinating
Time Frame: 6 weeks after surgery
Y/N Have you experienced difficulty urinating?
6 weeks after surgery
patient-reported difficulty with bowel movements
Time Frame: Baseline prior to surgery
Y/N Have you experienced difficulty with bowel movements?
Baseline prior to surgery
patient-reported difficulty with bowel movements
Time Frame: 72 hours after surgery
Y/N Have you experienced difficulty with bowel movements?
72 hours after surgery
patient-reported difficulty with bowel movements
Time Frame: 1 week after surgery
Y/N Have you experienced difficulty with bowel movements?
1 week after surgery
patient-reported difficulty with bowel movements
Time Frame: 3 weeks after surgery
Y/N Have you experienced difficulty with bowel movements?
3 weeks after surgery
patient-reported difficulty with bowel movements
Time Frame: 6 weeks after surgery
Y/N Have you experienced difficulty with bowel movements?
6 weeks after surgery
patient-reported skin changes or breakdown
Time Frame: Baseline prior to surgery
Y/N Have you experienced skin changes or skin breakdown?
Baseline prior to surgery
patient-reported skin changes or breakdown
Time Frame: 72 hours after surgery
Y/N Have you experienced skin changes or skin breakdown?
72 hours after surgery
patient-reported skin changes or breakdown
Time Frame: 1 week after surgery
Y/N Have you experienced skin changes or skin breakdown?
1 week after surgery
patient-reported skin changes or breakdown
Time Frame: 3 weeks after surgery
Y/N Have you experienced skin changes or skin breakdown?
3 weeks after surgery
patient-reported skin changes or breakdown
Time Frame: 6 weeks after surgery
Y/N Have you experienced skin changes or skin breakdown?
6 weeks after surgery
patient-reported sexual disfunction or erectile disfunction
Time Frame: Baseline prior to surgery
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Baseline prior to surgery
patient-reported sexual disfunction or erectile disfunction
Time Frame: 72 hours after surgery
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
72 hours after surgery
patient-reported sexual disfunction or erectile disfunction
Time Frame: 1 week after surgery
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
1 week after surgery
patient-reported sexual disfunction or erectile disfunction
Time Frame: 3 weeks after surgery
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
3 weeks after surgery
patient-reported sexual disfunction or erectile disfunction
Time Frame: 6 weeks after surgery
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vehniah K Tjong, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00214620

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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