Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038709
• Other study ID #: STU00214620
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: Melissa J Shauver, MPH
• Phone: 312-472-6024
• Email: melissa.shauver1[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries
• Hip Osteoarthritis
• Hip Strain
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University Department of Orthopaedic Surgery	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-reported post-operative numbness	Y/N Are you experiencing complete or partial numbness prior to your surgery?	Baseline prior to surgery
Primary	patient-reported post-operative numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	72 hours after surgery
Primary	patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	1 week after surgery
Primary	patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	3 weeks after surgery
Primary	patient-reported numbness	Y/N Are you experiencing complete or partial numbness as a result of your surgery?	6 weeks after surgery
Secondary	patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	Baseline prior to surgery
Secondary	patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	72 hours after surgery
Secondary	patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	1 week after surgery
Secondary	patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	3 weeks after surgery
Secondary	patient-reported difficulty urinating	Y/N Have you experienced difficulty urinating?	6 weeks after surgery
Secondary	patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	Baseline prior to surgery
Secondary	patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	72 hours after surgery
Secondary	patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	1 week after surgery
Secondary	patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	3 weeks after surgery
Secondary	patient-reported difficulty with bowel movements	Y/N Have you experienced difficulty with bowel movements?	6 weeks after surgery
Secondary	patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	Baseline prior to surgery
Secondary	patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	72 hours after surgery
Secondary	patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	1 week after surgery
Secondary	patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	3 weeks after surgery
Secondary	patient-reported skin changes or breakdown	Y/N Have you experienced skin changes or skin breakdown?	6 weeks after surgery
Secondary	patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	Baseline prior to surgery
Secondary	patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	72 hours after surgery
Secondary	patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	1 week after surgery
Secondary	patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	3 weeks after surgery
Secondary	patient-reported sexual disfunction or erectile disfunction	Y/N Have you experienced sexual dysfunction/erectile dysfunction?	6 weeks after surgery