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Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Primary Purpose

Hip Osteoarthritis, Hip Injuries, Hip Sprain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Pink Pad Hip Kit
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Osteoarthritis focused on measuring arthroscopy, traction

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Department of Orthopaedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pink Pad

Control (No pad)

Arm Description

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.

Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post.

Outcomes

Primary Outcome Measures

patient-reported post-operative numbness
Y/N Are you experiencing complete or partial numbness prior to your surgery?
patient-reported post-operative numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?

Secondary Outcome Measures

patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?

Full Information

First Posted
September 1, 2021
Last Updated
January 24, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05038709
Brief Title
Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness
Official Title
Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Injuries, Hip Sprain, Hip Strain
Keywords
arthroscopy, traction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pink Pad
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (No pad)
Arm Type
No Intervention
Arm Description
Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post.
Intervention Type
Device
Intervention Name(s)
The Pink Pad Hip Kit
Other Intervention Name(s)
Xodus Medical
Intervention Description
The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.
Primary Outcome Measure Information:
Title
patient-reported post-operative numbness
Description
Y/N Are you experiencing complete or partial numbness prior to your surgery?
Time Frame
Baseline prior to surgery
Title
patient-reported post-operative numbness
Description
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Time Frame
72 hours after surgery
Title
patient-reported numbness
Description
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Time Frame
1 week after surgery
Title
patient-reported numbness
Description
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Time Frame
3 weeks after surgery
Title
patient-reported numbness
Description
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
patient-reported difficulty urinating
Description
Y/N Have you experienced difficulty urinating?
Time Frame
Baseline prior to surgery
Title
patient-reported difficulty urinating
Description
Y/N Have you experienced difficulty urinating?
Time Frame
72 hours after surgery
Title
patient-reported difficulty urinating
Description
Y/N Have you experienced difficulty urinating?
Time Frame
1 week after surgery
Title
patient-reported difficulty urinating
Description
Y/N Have you experienced difficulty urinating?
Time Frame
3 weeks after surgery
Title
patient-reported difficulty urinating
Description
Y/N Have you experienced difficulty urinating?
Time Frame
6 weeks after surgery
Title
patient-reported difficulty with bowel movements
Description
Y/N Have you experienced difficulty with bowel movements?
Time Frame
Baseline prior to surgery
Title
patient-reported difficulty with bowel movements
Description
Y/N Have you experienced difficulty with bowel movements?
Time Frame
72 hours after surgery
Title
patient-reported difficulty with bowel movements
Description
Y/N Have you experienced difficulty with bowel movements?
Time Frame
1 week after surgery
Title
patient-reported difficulty with bowel movements
Description
Y/N Have you experienced difficulty with bowel movements?
Time Frame
3 weeks after surgery
Title
patient-reported difficulty with bowel movements
Description
Y/N Have you experienced difficulty with bowel movements?
Time Frame
6 weeks after surgery
Title
patient-reported skin changes or breakdown
Description
Y/N Have you experienced skin changes or skin breakdown?
Time Frame
Baseline prior to surgery
Title
patient-reported skin changes or breakdown
Description
Y/N Have you experienced skin changes or skin breakdown?
Time Frame
72 hours after surgery
Title
patient-reported skin changes or breakdown
Description
Y/N Have you experienced skin changes or skin breakdown?
Time Frame
1 week after surgery
Title
patient-reported skin changes or breakdown
Description
Y/N Have you experienced skin changes or skin breakdown?
Time Frame
3 weeks after surgery
Title
patient-reported skin changes or breakdown
Description
Y/N Have you experienced skin changes or skin breakdown?
Time Frame
6 weeks after surgery
Title
patient-reported sexual disfunction or erectile disfunction
Description
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Time Frame
Baseline prior to surgery
Title
patient-reported sexual disfunction or erectile disfunction
Description
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Time Frame
72 hours after surgery
Title
patient-reported sexual disfunction or erectile disfunction
Description
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Time Frame
1 week after surgery
Title
patient-reported sexual disfunction or erectile disfunction
Description
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Time Frame
3 weeks after surgery
Title
patient-reported sexual disfunction or erectile disfunction
Description
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Time Frame
6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa J Shauver, MPH
Phone
312-472-6024
Email
melissa.shauver1@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Barrett, BS
Phone
312-472-6715
Email
joshua.barrett@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vehniah K Tjong, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Orthopaedic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Barrett, BS
Phone
312-472-6715
Email
joshua.barrett@northwestern.edu

12. IPD Sharing Statement

Learn more about this trial

Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

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