Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

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: Recruiting
• Conditions: Hip Injuries; Hip Osteoarthritis; Hip Sprain; Hip Strain
• Intervention / Treatment: Device: The Pink Pad Hip Kit

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa J Shauver, MPH; Phone Number: 312-472-6024; Email: melissa.shauver1@nm.org
• Study Contact Backup: Name: Joshua Barrett, BS; Phone Number: 312-472-6715; Email: joshua.barrett@nm.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Department of Orthopaedic Surgery
      • Contact: Joshua Barrett, BS; Phone Number: 312-472-6715; Email: joshua.barrett@northwestern.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
patient-reported post-operative numbness	Y/N Are you experiencing complete or partial numbness prior to your surgery?	Baseline prior to surgery
patient-reported post-operative numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	72 hours after surgery
patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	1 week after surgery
patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	3 weeks after surgery
patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	Baseline prior to surgery
patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	72 hours after surgery
patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	1 week after surgery
patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	3 weeks after surgery
patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	6 weeks after surgery
patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	Baseline prior to surgery
patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	72 hours after surgery
patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	1 week after surgery
patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	3 weeks after surgery
patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	6 weeks after surgery
patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	Baseline prior to surgery
patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	72 hours after surgery
patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	1 week after surgery
patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	3 weeks after surgery
patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	6 weeks after surgery
patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	Baseline prior to surgery
patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	72 hours after surgery
patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	1 week after surgery
patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	3 weeks after surgery
patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	6 weeks after surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Vehniah K Tjong, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: arthroscopy; traction
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Hip Injuries
• Other Study ID 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